Podcasts about class iii

There's milk everywhere: more milk in the U.S., Europe and New Zealand than a year ago, soft Class IV, and Class III futures that could slip into the $13s once you plug in today's spot cheese and whey. With a long milk wave crashing over the dairy industry, will farmers start culling cows and leaving stalls empty? Inside the episode, the team churns through: Why strong balance sheets, paid-down debt and high cow values could delay a production pullback How lower feed costs shift the breakeven – but can't fully offset falling milk checks Why Western and cheese-focused regions like the Pacific Northwest, California and Idaho may struggle first How WPC 80, WPI and clear whey proteins have become the lone bulls – and why capacity constraints limit the industry's response Why there are limits to what customers can pay for whey, and where substitution is already happening It's a barn full of bears on butter, cheese and fluid milk, but the protein complex is still flexing. The question is how long that can last? Tune in to The Milk Check episode 88: One bull in a barn full of bears to hear how our traders are navigating a market that's bearish on volume but still bullish on protein. Got questions? We'd love to hear them. Submit below, and we might answer it on the show. Ask The Milk Check Ted Jacoby III: Welcome, everybody, to The Milk Check. It is December 5th. We’re gonna talk about markets today. And rather than boring you and having the same conversation we had three weeks ago, everything is still bearish. There’s milk everywhere. There’s milk all over the U.S. There’s milk all over Europe. There’s milk all over New Zealand. There’s a whole bunch more milk this year than last year. Things are long. It’s very likely things are gonna get longer before they get shorter. Today we have some of our usual suspects. My brother Gus has joined us today. We’ve got Josh White, we’ve got Joe Maixner, we’ve got Diego Carvallo. And, of course, myself. Looking forward to a great conversation. So, rather than discussing how bearish we can be on these markets, my question, and I’m gonna start by throwing this question at my brother, Gus, is Gus, how long do you think it’s gonna take for dairy farmers to start culling cows and for this milk [00:01:00] production to slow down? Gus Jacoby: I feel like milk price and farm economics are completely contingent on that and how bad those farm economics get with respect to the milk price. Class III is still relatively high. Obviously, Class IV is pretty poor right now. The way I see it, dairymen, at this moment in time, still have fairly strong balance sheets. So, the recent low prices haven’t affected ’em all that much. So, I don’t expect their behavior with respect to culling and whatnot to change. But I think in five, six months from now, assuming that the milk price is at or lower, and quite frankly, I think Class III probably does need to get a bit lower, you’ll start to see some of that behavior change. If I had to guess, either as early as early summer, but as late as maybe mid-fall, if farm economics don’t change, we’ll start to see dairymen begin to leave stalls open. I mean, they’re gonna cull a cow, collect that beef revenue that they can grab, and not necessarily buy the expensive heifer. Ted Jacoby III: You’re thinking it’s gonna take about six months for dairy farmers [00:02:00] to get to the point where they feel like they need to increase the amount of cows they’re selling in order to meet their cashflow needs? Gus Jacoby: That’s my best guess. And again, that can be either expedited or slowed down depending on where the milk price goes. Ted Jacoby III: Corn prices have really come down this year. Do you think the lower feed prices have lowered where that break even point is, or how low we need to go in milk price in order to really send those signals in a strong way? Gus Jacoby: Certainly, feed prices being lower are gonna be helpful to the farm economic model. This becomes a milk price discussion. If the cheese price continues to have that downward pressure and gets low enough, those feed prices won’t be low enough. It’s always related to their inputs. And certainly, cheap feed helps their cause to extend growth in the milk production model. Ted Jacoby III: Right now, on December 5th, the Class III prices for the first quarter are right around, let’s call it $15.50, but if you use today’s cheese price on the spot market at the CME in today’s whey price, you’re probably looking at something closer to $14, 14 and a quarter. [00:03:00] Is that low enough or do we need to go lower? Gus Jacoby: It’s low enough. But not low to expedite anything. Maybe that takes us into the late summer, and remember, it depends on where we’re talking here in the country. Milk production costs are different depending on where you exist in the country. And also payouts are a lot different in a lot of places, depending on where you exist in the country. So, some regions might struggle sooner than later. Ted Jacoby III: Which regions do you think are gonna struggle first? Gus Jacoby: The West, Pacific Northwest, I think California, areas like Idaho that are strongly cheese based. If you’re paying on a Class III price and it stabilizes, which I don’t anticipate here, then perhaps some of those regions might hold on longer. My guess is predicated on the forecast of Class III going a bit lower. Ted Jacoby III: I guess I’d have to agree with that ’cause I don’t think $14 a hundredweight is enough. Because we’re still in front of Christmas, and I think the market’s probably gonna get worse before it gets better. My hunch is we’re gonna see $13 milk this year. We’re gonna see it in Class IV, and we may be already [00:04:00] seeing it in Class IV as soon as December. I think we’re gonna see a 13 handle in Class III, probably most of the first quarter. Gus Jacoby: If you’ve got a Class III at 13, and Class IV holds as low as it is, which I would expect certainly in the first half of the year, and then you have your standard freight and other deducts in those milk checks, dairymen are now getting to an area that is very adverse. Ted Jacoby III: Even though we’re talking about really low prices, I think there’s a lot of dairy farmers out there that are in a pretty healthy place. Gus Jacoby: I would agree. Ted Jacoby III: They’re healthy in two ways. One, I think that many of them have been able to take the last two years and really pay down their debt. And so, they’re in a really good spot financially, just on the balance sheet alone. But the second thing is those cows, they’re worth twice what they were worth three years ago. And so, not only have they paid down their debt, but if they need to borrow more, they’ve got more collateral to borrow against because those cows are usually the collateral for the banks when the banks lend dairy farmers money. It’s [00:05:00] usually the cows and the land. My hunch is that this may go on longer than we expect because of how healthy dairy farmers are financially today. Not saying they’ll be healthy in four or five months, but they’re healthy today. And because of how much bankers are probably willing to lend them based on those balance sheets. Gus Jacoby: I agree that the balance sheets are strong at the moment, even after a couple tough months. But I would also add, that that can change fairly quickly if the milk price gets low enough. And it’s certainly a ratio of farm economics over a certain period of time and milk price. If it gets low enough and makes those farm economics adverse enough, it can expedite the issue, which is a plausible scenario right now. Ted Jacoby III: Mm-hmm. I would agree with that. I think the hardest thing, especially when you have a falling market like we do right now, is to try and figure out exactly where the bottom is. About a month ago, the bottom was about a $1.40. Well, guess what? Cheese price is already below a $1.40 Now, we’re hearing it’s gonna be [00:06:00] somewhere in the $1.20s. What I’m scared is we’re gonna get to the $1.20s, and somebody’s gonna start talking about maybe we need to go into the teens. I don’t know if we’re gonna go that low, but we’re definitely in that scenario right now, where you have a market that’s falling and nobody has a really good feel for where that bottom is. Gus Jacoby: I agree. Cheese and butter right now, their outlook over the next six to eight months does not look good. Ted Jacoby III: Yeah. You mentioned butter. Joe, I’ll ask you: we’re below a $1.50 in butter. Butter feels like maybe it’s caught a temporary floor. Is this a temporary floor or could we stabilize here for the next six months? Joe Maixner: I think we’ve hit a temporary floor, but I don’t think it’s the lowest we’ll see over the next 90 days. I think that cream seems to be in balance, even after Thanksgiving, and I think it’s kept a nice spot in the market where people are willing to buy, those that hadn’t already put contracts on for next year are seeing the 2026 numbers and they’re looking at that against their budgets and blocking volume up for next year. A [00:07:00] lot of first half volume’s already been booked. We’re just seeing more activity. We’ve hit that level of support. Ted Jacoby III: Joe, you mentioned cream. Gus, I’m gonna go back to you. We had some really ugly cream multiples the first half of last year. Have we increased churn capacity, and do we expect those multiples to be just as bad this year or have we increased churn capacity enough so that maybe they won’t quite get so bad? Gus Jacoby: We have increased churn capacity, certainly. I don’t know if it’s enough. Some dairymen around the country are feeding their rations a bit different and getting a little bit less butterfat out of the milk. I don’t think that’s enough, yet, to make too much change. I will anticipate having some very low multiples through the holidays and the spring flush. Ted Jacoby III: Okay. Diego, I’m gonna switch gears and come to you. We just talked about U.S. milk production. Gus thinks it’ll take about six months to turn. I hate to be really pessimistic, but my gut, and I just can’t shake this gut, is it’s gonna take longer than usual this time around. And we may see it go well past nine months before we see a real turn. [00:08:00] We may see the number get better simply because we’re measuring against strength, but that doesn’t mean we actually see a change in trend. What about Europe and some of the other milking regions in the world, is it gonna take that long us to see some changes in milk production in those regions? Diego Carvallo: If you just go to the fundamentals and you analyze that the European farmer usually has a smaller scale, and that means that their costs tend to be a little bit on the higher end. They do not have access to capital as there is in the U.S. There’s more restrictions when it comes to environmental, and overall I would say they have more headwinds than the U.S. So, if you add to all of those headwinds, the price headwind, the reaction on milk production to lower prices should be faster than in the U.S. The same applies to South America. But we’ve talked a lot about Chinese production, we know that in that country, there are way more things to take into account. Ted Jacoby III: [00:09:00] So, we’ve been talking a lot about the supply side today. We’re just overwhelming supply on the butter side; we’re overwhelming demand to a lesser extent, but still on the cheese side. Josh, protein still tends to be the shining star. But are we getting to a point where we’re starting to get some pushback on protein prices? And is that going to continue to be the lone bull in an overall bearish dairy market, or do we need to be concerned there too? Josh White: I don’t think we’re getting pushback at the prices quite yet. Does that mean I think that these prices are palatable over the long term? I’m unsure. But what we are seeing right now is lack of availability and no quick ability by the European market or the U.S. market to scale production to meet the demand, which means that ultimately, the demand for WPC 80 and WPI and then some of the more value-added proteins, particularly in the whey complex, like the clear WPIs, the acidified products and others, the demand is outpacing our ability to supply it. What that’s [00:10:00] doing is forcing utilization segments or customers that can’t compete in terms of price for that available supply to look to alternatives. We’re starting to see more and more of that. As a commodity trader, we expect that to happen quicker than it does. So, already in early 2025, we were looking towards MPCs, casein-related products and others to pick up some of that demand because they’re much lower value. And I don’t think that the average customer in the market that’s using whey proteins fully recognize the functional differences between whey proteins and milk proteins. And they certainly don’t realize that milk protein concentrate has whey protein in it. Generally speaking, the average consumer doesn’t know the difference in these products. That’s not a fault of theirs. Particularly going into CPG applications and further processing, this is an ingredient. An ingredient that has a lot of label recognition and popularity right now for all the reasons we’ve talked about in prior podcasts: GLP-1 driven demand, [00:11:00] health and wellness movements globally, a lot of other reasons. Is that an early indication that enough time has now passed that the relative value of whey protein above the competing, but still quite valuable proteins in the dairy complex, are gonna result in substitution both substitution within the dairy category to whey protein to milk protein concentrates to micellar casein to WPC 70, also known as WPPC, whey protein phospholipid concentrate (WPPC) ProCream. There’s a lot of different names for these products. That’s likely to happen. But it also, unfortunately, might result in a lot of categories pushing to non-dairy proteins. There’s a lot of information out there, things put on by ADPI and others talking about the protein power of dairy and how digestible it is. How high quality it is for your conversion rate, why it’s such a popular thing. But if you can’t get supply, you’re forced to look to alternatives. And so, we’re starting to see some of that [00:12:00] happen. So, a couple things that I’ve heard anecdotally in the market over the past few weeks in particular, but it’s been happening over the last few months are: get us samples of milk protein concentrate. One of our customers is suspending a certain SKU on the shelf because they can’t get the supply. This price simply won’t work for our application. So, we won’t buy this product at above this price. So, we are triggering some thresholds. And triggering thresholds is gonna have some type of balancing result in the industry. Whether that’s enough to support the milk protein side of the equation, I don’t know. We have a limit to the ability to respond to this demand. You have to order equipment, you have to get the bank lending, you’ve gotta get the design. It takes a long time to increase capacity. That’s all gonna come into play and impact this market and the balance of this market in 2026. Now, if you’re asking me, is my gut that we hold these high prices or even higher prices without some reversal in the price [00:13:00] action for whey proteins in 2026? I’m not ready to say that it’s just here or higher in 26, but is it here or higher in the first quarter? Absolutely. Is it here higher in the second quarter, probably. Is it here or higher after that? I become a little bit skeptical. And to be clear, that’s not because the demand isn’t there right now. The demand feels like it’s there. I just don’t know how the market balances it out without pushing the price just too high in the short term for the market to digest it and pass it through. I also think that when you’re talking about the dairymen and you’re talking about the cheese makers, there is two different classes here. There is the class of those that make whey proteins and the class of those that do not. That has a material impact on profitability throughout the supply chain. Additionally, we’ve got a lot of milk in the U.S. We’ve got a lot of milk in the world right now, and the milk in the Northern hemisphere altogether is only gonna increase from here through the first half of [00:14:00] the year. That milk is gonna need to be processed. The incremental milk production will result in incremental whey protein availability, which means that those whey solids from cheese processors they have to find a market. If you can’t make the valuable product of WPC 80 and WPI, you have to explore the other alternatives, which are simply not experiencing the robust demand of those two categories. Sweet whey powder, whey protein concentrate 34% (WPC 34) and some of these other products, they have a limit to what people are willing to pay. History tells us, at least for sweet whey powder, we’re testing those limits. Ted Jacoby III: For sweet whey powder, we are, the question is, is this happening for whey protein? And that’s a harder one to answer. Josh White: Absolutely. Ted Jacoby III: I did some back of the envelope math. As a country, we produce 8% to 9% more milk in May on a daily basis than we do in November. If half of that milk goes into cheese, we’ll produce 8% more cheese and 8% perhaps more whey protein. The solids change, too. So, maybe it’s not a full [00:15:00] 8%, but is 8% enough to tip the scale on whey protein demand? And I don’t know, given the demand complex for whey, I think for cheese it’s gonna feel very burdensome. I think for butter, it would probably feel pretty burdensome. The butter market we’re kind of used to it because of the way the demand curve looks, but I just don’t know when it comes to whey, if that’s enough to put some pressure on this market and bring those prices down. Josh White: Well, it depends on what you’re talking about because you could argue that the WPC and WPI facilities are bringing in outside whey solids. Mm-hmm. Mm-hmm. As their own milk and their own whey generation increases seasonally, that’s gonna push whey solids back to somebody else. So, all 8% in your hypothesis there, I doubt contributes to an 8% increase in whey protein production. Because the available capacity isn’t there? Josh White: Correct. Now, is there production efficiencies that are still gonna be gained? Are there those out there that are expanding a bit [00:16:00] that we’re unaware of? Are there orders for new equipment in the system that might be closer to realization than we think? All possible. And we can’t ignore Europe. I don’t feel like I can adequately represent what the expansion model looks like in Europe right now for whey proteins. What I can say is that at least for the U.S. and Europe, our internal demand is currently absorbing a greater percentage of our production than ever before, and that’s leaving the rest of the world that was buying product from those two markets, having to search for that protein elsewhere. Ted Jacoby III: Mm-hmm. Josh White: And, this is being a bit over generic, but the rest of the world likely will be more willing to substitute than the U.S. or the European consumer to other products. Ted Jacoby III: I would agree with that. Everybody in our office is just leaning really bearish, just about everybody we talk to seems to be leaning really bearish. Josh White: Outside of Black Swan events: major trade disruptions, major production impacts that we can’t predict. If you’ve [00:17:00] been in the dairy industry long enough, you know to never bet against the dairymen and their ability to make milk. But it’s gotta be on the radar that the competitive dollars for those animals I don’t think has ever been as lucrative as it is right now. And those animals that they’re currently milking are older then typically they want them to be. So, if we shift this cycle quickly enough and violently enough, and that’s price, at what moment do we get surprised at what that residual response is? How many pent up animals find their way to slaughter? How quickly that could happen. And I think generally speaking, most of us would bet that the calf inside the dairy cow right now is worth enough to wait. And so, we’ve gotta get through the first half of the Northern Hemisphere season before we see much of an animal response. Ted Jacoby III: I think that’s a fair comment. Dairy farmers, especially the big financially astute ones, there’s a math equation. It’s like, this is my revenue [00:18:00] from milk. This is my maybe revenue from biofuels or wherever else. They have revenue streams from a cow that’s giving milk every day. This is the cost to maintain that cow. The variable cost feed, for example, being the big one. Well, when you’re getting $20, a hundredweight from your milk versus $13, a hundredweight for your milk. That equation has changed quite a bit, whereas the exit price, what you’re gonna get if you sell the cow hasn’t changed at all, which means your math equation, the exit possibility has definitely gone up. It’s more profitable to sell this cow than it used to be. Josh White: History tells us that the exits of the older dairymen and the smaller dairies doesn’t really change based on economic conditions, it’s relatively stable. Maybe there’s some risk that we have some pent up exits and some risk that it’s never been a better time to retire. Mm-hmm. And you get some smaller dairies that decide to exit. That doesn’t move the needle. Ted Jacoby III: I would suspect. You’re right. We’ll see. Josh White: One [00:19:00] quick remark that’s important is the outlook on demand. It seems like the market is very, very bearish because supply is outpacing demand globally and it’s in every major milk shed. But demand by import regions has been pretty good. Mm-hmm. They’ve been buying year over year, more dairy products. At the same time, I don’t believe there’s any region in the world that’s currently sitting on cumbersome overall dairy stocks, whether that’s from the import regions or the production regions. Everyone seems to be quite aware that you gotta stay in front of this. I don’t know how to interpret that. On one hand, you could say that based on some of the economic outlooks, globally, we shouldn’t be expecting things to get better. We should be expecting them to get at best the same or possibly even worse. On the other side of that equation is import dairy consumption and demand is growing and continues to grow, so it might be a painful period, but the long-term [00:20:00] outlook remains pretty good, and we just overreacted to some of the demand signals that we have. Credit to the dairymen in the world, being able to respond to signals that we needed more fat, not even a year ago. That whey protein demand’s good. I mean, the market has responded, but overall we’re not talking about an oversupply situation because demand’s bad. If you go granularly, like U.S. cheese consumption, doesn’t look real great right now. The outlook for overall economic health, I’m not an expert in that area, but I’m not seeing a lot of people talking about a rosy 12 to 24 months there. So, yeah, I think generally speaking, it’s easy to be bearish, but maybe that’s one thing to pay attention. Ted Jacoby III: You mentioned demand. I happened to be involved in a conversation yesterday with an equities trader and his comment about stock valuations, equities, valuations, which was really a demand comment, was, I’m just waiting to see what Christmas sales do. I think there’s a lot of people out there right now that are trying to get a feel for what’s [00:21:00] the long-term demand or the 2026 demand perspective, and I think a lot of them are gonna judge what it really is based on how this holiday season plays out. All right guys. Hey, thanks for a great conversation. I apologize to all the dairy farmers out there that I couldn’t give you any better news, but hang in there that good news will come eventually. That’s right.

Contributor: Aaron Lessen, MD Educational Pearls: How do amiodarone and lidocaine work on the heart? Amiodarone Blocks potassium channels (Class III effect). Also blocks sodium and calcium channels. Additional noncompetitive beta-blocker effects. Stabilizes cardiac tissue, slows heart rate, and suppresses both atrial and ventricular arrhythmias. Lidocaine Blocks fast sodium channels in ventricular tissue (Class Ib). Shortens the action potential in ventricular myocardium, especially in ischemic tissue. Suppresses abnormal automaticity in damaged/irritable myocardium. Which one should you pick for a patient in vtach/vfib cardiac arrest? The current guidelines recommend amiodarone for shock-refractory cases but this is based on randomized trials showing better arrhythmia termination and short-term outcomes, but not long-term survival benefits. Two recent studies suggest that lidocaine might actually be preferable. A 2023 paper published in Chest Performed a large retrospective cohort study for treating in-hospital VT/VF cardiac arrest. Among more than 14,000 patients, lidocaine was associated with higher rates of ROSC, 24-hour survival, survival to discharge, and favorable neurologic outcomes. These results held after adjusting for covariates and using propensity score methods. Overall, lidocaine outperformed amiodarone across all major clinical outcomes in this population. A 2025 paper published in Resuscitation Performed a target trial emulation in adults with out-of-hospital shockable cardiac arrest. After propensity score matching in more than 23,000 eligible cases, lidocaine was associated with higher odds of prehospital ROSC, fewer post-drug defibrillations, and greater survival to hospital discharge. These advantages were consistent across matched patient pairs. Dose for lidocaine is an initial 1-1.5 mg/kg IV bolus, followed by additional boluses of 0.5-0.75 mg/kg every 5-10 minutes up to a total of 3 mg/kg if needed. Dose for amiodarone is a 300 mg bolus followed by an additional 150 mg bolus if needed. References Al-Khatib SM, Stevenson WG, Ackerman MJ, Bryant WJ, Callans DJ, Curtis AB, Deal BJ, Dickfeld T, Field ME, Fonarow GC, Gillis AM, Granger CB, Hammill SC, Hlatky MA, Joglar JA, Kay GN, Matlock DD, Myerburg RJ, Page RL. 2017 AHA/ACC/HRS guideline for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: Executive summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Heart Rhythm. 2018 Oct;15(10):e190-e252. doi: 10.1016/j.hrthm.2017.10.035. Epub 2017 Oct 30. Erratum in: Heart Rhythm. 2018 Nov;15(11):e278-e281. doi: 10.1016/j.hrthm.2018.09.026. PMID: 29097320. Smida T, Crowe R, Price BS, Scheidler J, Martin PS, Shukis M, Bardes J. A retrospective 'target trial emulation' comparing amiodarone and lidocaine for adult out-of-hospital cardiac arrest resuscitation. Resuscitation. 2025 Mar;208:110515. doi: 10.1016/j.resuscitation.2025.110515. Epub 2025 Jan 23. PMID: 39863130; PMCID: PMC11908894. Wagner D, Kronick SL, Nawer H, Cranford JA, Bradley SM, Neumar RW. Comparative Effectiveness of Amiodarone and Lidocaine for the Treatment of In-Hospital Cardiac Arrest. Chest. 2023 May;163(5):1109-1119. doi: 10.1016/j.chest.2022.10.024. Epub 2022 Nov 2. PMID: 36332663. Summarized by Jeffrey Olson, MS4 | Edited by Jeffrey Olson and Jorge Chalit, OMS4 Donate: https://emergencymedicalminute.org/donate/

This episode highlights Airbus kicking its A350 freighter program into high gear, with the prototype finalized and flight tests set for next October, aiming for a late 2027 service entry. Learn how the A350F promises a 40% reduction in fuel consumption and features a massive 175-inch wide cargo door, giving it a significant edge in handling bulky industrial cargo. We also examine major rail consolidation, specifically the Surface Transportation Board approval of Fortress Investment Group's acquisition of two new regional lines, the Wheeling & Lake Erie Railway and the Akron Barberton Cluster Railway. This deal expands Fortress's roster of Class III railroads, and the STB agreed that the move would enhance the railways' access to capital for strategic investment and growth. Finally, we cover the worrying financial distress facing the 3PL sector as Odyssey Logistics was hit with a second debt downgrade from Moody's in less than three months, dropping its corporate family rating deep into Caa-1 "junk status". Moody's noted this rapid deterioration was driven by sky-high leverage—expected well over seven times operating profit—which creates serious refinancing risk ahead of the company's significant debt maturities in 2027. Learn more about your ad choices. Visit megaphone.fm/adchoices

This episode highlights Airbus kicking its A350 freighter program into high gear, with the prototype finalized and flight tests set for next October, aiming for a late 2027 service entry. Learn how the A350F promises a 40% reduction in fuel consumption and features a massive 175-inch wide cargo door, giving it a significant edge in handling bulky industrial cargo. We also examine major rail consolidation, specifically the Surface Transportation Board approval of Fortress Investment Group's acquisition of two new regional lines, the Wheeling & Lake Erie Railway and the Akron Barberton Cluster Railway. This deal expands Fortress's roster of Class III railroads, and the STB agreed that the move would enhance the railways' access to capital for strategic investment and growth. Finally, we cover the worrying financial distress facing the 3PL sector as Odyssey Logistics was hit with a second debt downgrade from Moody's in less than three months, dropping its corporate family rating deep into Caa-1 "junk status". Moody's noted this rapid deterioration was driven by sky-high leverage—expected well over seven times operating profit—which creates serious refinancing risk ahead of the company's significant debt maturities in 2027. Learn more about your ad choices. Visit megaphone.fm/adchoices

Breaking news! The FAA has made significant changes to the policy on reporting Unidentified Anomalous Phenomena (UAP). UAP reports generated by air traffic controllers will use the acronym UAP instead of UFO, and controllers are required to provide specific information about the UAP in their reports.Also in this episode, Todd Curtis and John Goglia discuss two 2025 fatal accidents in which pilot medical conditions may have been an issue. Todd and John discuss how aging brings issues that are a challenge for older pilots. The NTSB preliminary reports of the accidents under scrutiny do not include information on the age of the pilots. However, news media stories about the two crashes revealed that both pilots were in their 80s. Both pilots had BasicMed certifications.A BasicMed certificate must be renewed every four years and can be approved by any licensed physician. Class III and other medical certificates must be approved by an FAA-certified Aviation Medical Examiner (AME).While neither of the two NTSB preliminary reports mention a medical condition playing a role in either accident, the BasicMed process may expose older pilots to risks. John suggests that BasicMed should have restrictions, including not allowing older pilots with a BasicMed certificate to carry passengers.  Don't miss what's to come from the Flight Safety Detectives - subscribe to the Flight Safety Detectives YouTube channel, listen at your favorite podcast service and visit the Flight Safety Detectives website. Want to go deeper with the Flight Safety Detectives? Join our YouTube Membership program for exclusive perks like members-only live streams and Q&As and early access to episodes. Your membership support directly helps John, Greg and Todd to deliver expert insights into aviation safety.Interested in partnering with us? Sponsorship opportunities are available—brand mentions, episode integrations, and dedicated segments are just a few of the options. Flight Safety Detectives offers a direct connection with an engaged audience passionate about aviation and safety. Reach out to fsdsponsors@gmail.com. Music: “Inspirational Sports” license ASLC-22B89B29-052322DDB8 Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Milk production is up 4.2% year over year, components are climbing and prices are falling. As holiday orders wrap up and we head into the long winter, The Milk Check team digs into whether dairy markets have already found a floor, or if there's still another leg down to go. With milk products everywhere (except for whey), the Jacoby team shares where the market is and where we're going. They churn through: Butter at $1.50 and what heavy cream and higher components mean after the holidays Why cheese feels like a calm before the storm, and how far Class III could grind lower Nonfat and skim: long milk, growing inventories and buyers shopping the cheapest origin Why whey proteins are the outlier, with tight supply, strong demand and GLP-1 tailwinds Global milk growth, clustered demand (Ramadan, Chinese New Year, Super Bowl) and who blinks first between the U.S. and Europe In this episode of The Milk Check, host Ted Jacoby III is joined by Joe Maixner, Jacob Menge, Diego Carvallo, Josh White and Mike Brown for a rapid-fire market session on butter, cheese, nonfat and proteins. Listen now for The Milk Check's latest market read on butter, cheese, nonfat and whey. Got questions? We'd love to hear them. Submit below, and we might answer it on the show. Ask The Milk Check Ted Jacoby III: Welcome back, everybody, to The Milk Check podcast. Today we’re gonna have a market discussion. It is November 10th. We are in the last couple of weeks of the quote-unquote busy season, starting to get a feel for what we think is gonna happen to dairy markets as holiday orders are filled, and we transition into the long-term period of the year. In the last few weeks, we’ve actually seen prices drop, but it feels like butter’s kind of dropped down to about a $1.50/lb and seems to find at least a brief floor. We’ll talk to Joe and find out if Joe thinks we’re gonna stick around here for a while. The cheese market was up in the $1.80s/lb. It’s dropped to a little below $1.70, starting to hit a little bit of resistance. Jake will share with us a little bit about what we think is happening with cheese going forward. Nonfat dropped a little bit down to [00:01:00], about what Diego, about a $1.10/lb and had a little bounce off its floor. Meanwhile, the whey complex just continues to go up. We’ll check in with Josh and find out what’s going on there. Well, let’s go ahead and start with milk production. We just got released today, the September milk production, and it says it’s up 4.2%, which is a very, very big number. It’s November; milk is longer than it usually is this time of year. Usually, it’s quite tight, and it’s not quite tight, but I wouldn’t call it long. However, all the signs are there that once we get past the fall holiday order season, milk could get quite long. If September milk is up 4.2%, I think it’s safe to say that if that continues, we will be quite long milk as we transition from the typical seasonal tightness of the fall into the winter and the flush of the spring. 4.2% is a big number, and that’s not even taking into account the fact that the solids in the milk are up as well. That’s not the kind of tone that a dairy farmer wants us to set as we’re talking about what supply and demand looks like, but there’s a lot of milk out there, [00:02:00] Joe, does that mean there’s a lot of butter out there, too? Joe Maixner: Well, there’s still a lot of butter out there; sounds like there’s going to be a lot more butter coming soon. If milk’s up 4%, cream was heavy all of last winter and into last Spring, extremely heavy. If we have higher components, more milk, and we’ve got a full amount of milk coming outta California as well after coming off of bird flu last year, there’s just gonna be that much more cream in the system and more getting pushed back into the churns. So, it’s a very good possibility that we’re gonna go even lower than where we currently are. Volume seems to be trading well. The cream demand has been fairly steady, going into cultured products and the shorter shelf-life products. Cream’s still long, but it’s not swimming yet. Ted Jacoby III: Will we hold this $1.50 area through Thanksgiving, you think? Joe Maixner: Yeah, it seems like we’ve hit a spot where buyers are willing to step in. So, there’s a good chance that we could hang around this $1.50 area for the next couple of weeks. Once the last little spurt of holiday demand is over, we’re gonna take another leg lower. Ted Jacoby III: Okay. Jake, what about [00:03:00] cheese? Jacob Menge: I think we had a little reprieve from some cheese bearishness with the holiday demand. It’s tough, though, especially with this wall of milk that’s headed our way. Does it seem like the bottom’s ready to drop out? Probably not yet. But it still seems like it’s a possibility. It almost seems like the call before the storm. Ted Jacoby III: What you’re saying is: we’ve already dropped quite a bit, but we’re in typical low points, but it’s possible, considering the amount of supply coming our way, that there’s still another cliff to negotiate, and we could go a lot lower when it comes to Class III milk and cheese prices. Jacob Menge: If you zoom out a ways, going back to mid-2022, we’ve really not liked to go below that $1.55 level on futures. We’re kind of at another support level at this $1.65. Those seem like our two support areas, historically, for the last 3, 4 years. So, it’s probably gonna be one of those grinds lower if we move lower from here, versus that $1.85 to $1.65 was almost an air pocket drop. [00:04:00] It seems like the market’s gonna have to earn it if it moves lower from here, but it does seem like a possibility. Ted Jacoby III: When we get down to these levels, this usually tends to form the floor, and if we have so much cheese out there and so much milk out there that we’re gonna go lower from here, it’s probably not an air pocket drop; it’s probably a grind lower from here. Jacob Menge: Yeah, I think our lows, on the futures, for the past 4 years have been that $1.55. Don’t quote me on that, gimme a couple of cents on either side of that. But that means we got a dime from here to hit those five-year lows, you know, besides COVID. There’s a lot to be said for technical trading at those levels. So, it would take a big fundamental kind of wave supply to get us to crack that. Ted Jacoby III: Got it. Thank you. Diego. What about nonfat? What’s the international market doing? We know we have a lot of milk in North America. We have a lot of milk everywhere. And what does it mean? Diego Carvallo: Customers are also seeing the data, and it seems like they’re in no rush to buy nonfat. Right. Nonfat seems to be the product that is 00:05:00 consistently available. We haven’t seen a very tight market in several years. So, it seems customers are more concerned about other products like WPCs or maybe cheese, other products besides nonfat. So, they’re staying very hand-to-mouth. They’re being very flexible when it comes to origin and just buying spot and from the origin that offers them the cheapest skim milk powder delivered price, which, in most cases, for the past few months, has been either European or New Zealand product because of the shipment time, transit time, and tariffs. Ted Jacoby III: Has the inventory in the U.S. been building as a result? Diego Carvallo: Yes, it has, Ted. Yep. Inventory has been building. I was looking into the milk production numbers for September. California was relatively stable compared to the previous year. I think we grew by 2.5% versus the previous year. But the strong impact from avian [00:06:00] influenza was actually in October. So, that’s when we might see a big jump between California production for 2024 and California production for 2025. So, I thought the Milk Report was pretty bearish for nonfat. Next month could be as bearish or even more. I still believe that we’re gonna see a lot of product going into the dryers, and that’s gonna add pressure, and that’s gonna increase inventories for U.S. products. Ted Jacoby III: What does milk production look like in Europe? Diego Carvallo: They’re actually up quite a bit. I think their September number was also stronger than expected. I can’t recall the exact number, but it was stronger than expected, even though they have cut down on the farmer price, the FrieslandCampina, which is the number one benchmark. It still seems like, with corn moving lower, there’s still a number that incentivizes more milk production. For the next few months until we see a stronger cotton price, we’re gonna see plenty of milk from the U.S. and from Europe. Ted Jacoby III: [00:07:00] Okay, thanks. Appreciate it, Diego. Josh, so what about the protein market? Josh White: Yeah, same story. I don’t know why everybody else is having so many problems with their products because whey proteins are in demand and it continues to be very strong. WPC 80, WPI demand is outpacing supply. People are trying to book forward and can’t. By all reports, the demand on the consumer level remains pretty good. It’s a bit of an outlier. It’s definitely a mystery. A lot of the discussion centers around GLP-1 adoption in the U.S. Compared to a year ago, I think I read this morning, something like 12% of Americans are allegedly using GLP-1-related drugs for weight loss. Assuming that’s an accurate statistic, that’s a noteworthy number of people. There was a lot of discussion last year that as people come on things like Wegovy and Ozempic, at what moment do we mature to the point that people beginning their cycles of taking the drugs equal those coming off of those drugs? There’s just been a lot of headlines about more affordable access to these types of products. If that continues, that shifts this curve even a little bit further up. [00:08:00] What can reverse that trend or slow down the demand for the whey protein side? I think it takes a production response. I can imagine that any manufacturer that’s making whey-related products as a byproduct of their cheese production is exploring how to access this demand, in particular, the whey protein isolate demand. I don’t have the impression that equipment is any easier to get, and there are still plenty of obstacles in terms of making production changes at the processor side. It feels to me like at least through the first half of this year, we’re gonna continue to be under-supplied relative to the demand that’s out there. And I think it’s important to note that although we’re talking about good demand for these products, the GLP-1-related impact on the dairy market isn’t all positive. It’s certainly a positive on the whey protein side. Still, I think, as it relates to consumer demand for butterfat, cheese products, and some of the other snack foods that dairy products are used in, in the CPG space, people are consuming fewer calories. Throughout the rest of the world, this health and wellness [00:09:00] trend and this appetite for quality protein are everywhere. Their demand continues to be very strong internationally. Maybe a couple of other things that are noteworthy, maybe early indicators of the price stabilizing, it looks like Europe and the U.S. might be closer to parity for the first time in a while. So, we should watch that. We will see seasonal production levels start to increase a bit. I don’t know if that will one-for-one find its way into additional whey protein availability, but it certainly should help the situation as we get into heavier production months in the Northern hemisphere markets that produce these products. But other than that, demand remains very, very strong. Prices are firm. They appear they’ll continue to be through at minimum the first quarter. And I don’t think it’s going out on a ledge to say through the first half of the year. And then we’ll see what happens on the other side of it. But yeah, definitely a firm marketplace right now, Ted. Ted Jacoby III: What about milk protein concentrate, milk protein isolate? Are we starting to see the value of those products increase and close the gap between the [00:10:00] whey protein, since the whey proteins have gotten so expensive? Josh White: I’ll jump in and say we’re starting to see some early indications of that: people looking for substitutes where they can. If you’re not in these markets every day, you don’t know what products are available. If you’re in the CPG space or using it as one of many, many SKUs that you’re buying, you’re not aware of the functional properties and some of these other things. And there’s also a decision-making timeline that people have to consider. Not only are there labeling concerns and other things, but there’s a lot of protein that’s consumed as an ingredient and maybe not the primary ingredient. And oftentimes, those decisions are not easy to formulate or change, and they’re also made over larger durations of time, like annual pricing. We’ve had such a wide gap for a long enough time now that we have customers asking questions, and customers that are on the lower end of the valorization for these products are looking for substitutes. Those substitutes come in a couple of ways. They can come from substituting away from dairy, substituting for other [00:11:00] dairy or trading down to lower dairy-related protein products. We’re seeing people investigate all of them. Diego might be able to speak more precisely about what’s happening with the MPC prices. But generally speaking, the majority of people out there are starting to ask questions. I’m not so sure it’s having a material impact or moving the needle quite yet on substitution. Ted Jacoby III: Okay, well, it feels a little bit like a broken record. Milk everywhere, product everywhere except for whey, maybe that’s exactly the loop we’re in right now. Joe Maixner: We’ve talked a lot about supply and excess and whatnot, but demand, it feels like we’re increasingly teetering towards a crumbling economic situation with higher debt, people not having much discretionary income, and just overall demand being weak. Ted Jacoby III: So, if you’re looking at the demand numbers that we track, restaurant traffic is definitely down. It is clear that the economic environment we’re in, people’s pocketbooks are being stretched thin, and they’re cutting back on how often they go to restaurants and eat at [00:12:00] restaurants. Now, usually when that happens, there’s an offset into the retail side, and the retail side numbers usually go up a little bit. You are seeing that. Speaking to some of our branded customers, what they’re telling us is their sales are down, and the private label guys are saying, well, their sales are up, but frankly, not as much as they expected. The bottom has not dropped out yet. I think everybody’s watching it pretty closely. I think the industry’s concerned. I’ll leave it at that. Mike Brown: I think food service continues to be the big stickler on overall dairy sales. Grocery sales are okay. Food service continues to be weak, and that’s gonna affect us. Mm-hmm. Particularly, I think some of the high-fat products. Josh White: When we’re looking at it from the home front, it doesn’t feel real great, but if we’re looking at just how much additional milk we have globally, including out of Oceana and out of South America, and looking at how much of that surplus milk globally is being consumed in Asia right now, I mean they’ve been buying I wonder if that points to some brightness, at least some positives? Now, I also am a little [00:13:00] concerned that we have a consolidation of demand events, with Chinese New Year buying at the same time that Ramadan continues to move earlier and earlier every year. And prices are low right now. Feels like we might have a big concentration of demand that’s meant to satisfy local needs in the early part of 2026, but there has been a lot of international trade. Ted Jacoby III: I think you’re absolutely right. Ramadan and the Chinese New Year are both in February. Diego Carvallo: The word in the street, Ted, is that most of the Ramadan and New Year’s demand is gonna be fulfilled by the middle of November. Ted Jacoby III: In other words, by the time we get to January 1st, those orders are gone. Mike Brown: Yeah. And Super Bowl is 10 days before the start of Ramadan in the Chinese New Year. So, they’re all pretty close together. Josh White: I went back to saying that, hey, we’ve got a lot of milk globally, every surplus region’s producing more milk than expected. You mentioned earlier, Ted, that doesn’t even account for the component growth that we have here. That’s been fairly impressive. [00:14:00] What’s been interesting about that is it hasn’t felt this heavy. You might believe, well, it doesn’t feel as heavy because the Northern Hemisphere is at its low milk production points. Maybe it doesn’t feel as heavy because we’ve got a concentration of additional demand, but we’re trading a lot of anticipatory supply concerns. We’re really trading the fact that tomorrow we’re worried we have a lot of incremental milk, globally, that we don’t necessarily know where we’re gonna go with it. That’s not a reason to get bullish, to be super clear, but I do think that if we’re thinking through vulnerabilities in the market, that might be one. Ted Jacoby III: I would agree with that. I think there are three things that are probably keeping this market from going straight to the bottom. One, as you said, we’re at the low point seasonally for milk production in the Northern Hemisphere. Two, we are at the high point for demand everywhere. And three, you get to a certain point, and I think we are there in all products, we may actually be passed there in butter, but we are there in cheese, I think we’re there in nonfat, where [00:15:00] in order to go lower, you need to build up supply to the point where the inventories become actually burdensome, and I don’t think they have become burdensome yet, but I would expect that sometime in the first quarter of 2026, they will. You’ll start hearing reports that warehouses are full. You’ll start hearing reports that, from a cashflow perspective, whether it’s traders, whether it’s manufacturers, you have people who just need to dump inventory because they don’t have the cash flow to continue to hold inventory. Those are the things that drive markets to their lows. And so, if you think about the old saying: the cure for high prices is high prices, and the cure for low prices is low prices, that’s when you find out what the low price is, and then you go to that place that sends the strongest supply signal possible to suppliers that they need to cut back. Mike Brown: I was at a cattle show of all things this weekend and was talking with someone about feeding palm oil to get butterfat. His rule of thumb was that a pound of palm oil costs about a dollar, and you get about a 00:16:00 three-to-five-point increase in fat test from that. So, if you say 0.4 and you’re a 90-pound Holstein herd, that’s 0.36 pounds of fat. So, you’re paying a dollar to produce, there’s roughly 50, 60 cents worth of butter fat. So, we may start to see that come into conversations on rations. Josh White: And if we’re looking for optimism, I think that formula is pretty openly discussed in Europe as well. So, you’ve got a situation now where you have the on-farm milk price that is beginning to drop, the signals there that it needs to come down. It’s moving at a decent clip, to Diego’s point, maybe not enough to make any major change yet, but for planning purposes, things like feeding for fat might be a bit more vulnerable going forward there. So yeah, if we’re looking for what could start to correct our oversupply situation or what could potentially stabilize or support the market, we need time. I think that’s the most important thing that needs to happen, is we need time, and we need a milk price that curtails any additional production growth [00:17:00] for the moment so that demand can catch up. We talked about the U.S. situation and how the consumer spending situation doesn’t feel great. But globally, per capita butterfat consumption globally is growing. Per capita protein consumption is growing. We just need to give the demand time to catch up. Inventories might be starting to build, but they’re nowhere nearcumbersome. I would actually argue, our supply chain is still very thin. I wouldn’t even argue that we’re getting to a point where we’re normal by historical standards. I think that we have a pretty thin supply chain, and that’s everything from measurable inventory and reports, like cold storage reports and manufacturing stocks here in the U.S., but all the way through the pipeline. I don’t believe that many end users are sitting on excess product or have too many days in inventory. I think they’ve been quite comfortable buying hand-to-mouth. And the only product they’re being punished on right now for that is whey proteins. Ted Jacoby III: I think you’re right, Josh. I would agree with that statement. I think butter [00:18:00] is somewhat of an exception. Joe Maixner: I don’t know. Butter, it just depends on product mix, right? It’s CME eligible salted bulk. I think overall inventories are not burdensome. But we do have too much older CME-eligible salted bulk butter out there. Ted Jacoby III: That’s actually where I’m going, Joe. What do butter manufacturers do if they’re worried about having produced too many quarters and too many solids? They’ll just produce bulk. And so bulk is the overflow because they know the worst-case scenario, they can dump it onto the CME. And so that is where we end up with excess surplus, just like we get the same with a cheddar block in the cheese market. Josh White: How is international demand for U.S. butter at the moment, Joe, compared to where you would expect it to be and compared to where we were a few months ago? Joe Maixner: It’s steady right now. New inquiries are still coming in, but inquiries have lessened compared to a month or two ago; there’s a lot being made and shipping right now. International markets are starting to open their eyes to something other than [00:19:00] 82%. They’re starting to expand into the 80% because they are finally starting to realize that the numbers that they see on the futures don’t equate to the numbers they pay for an 82% product. And so anybody that’s really just using it for solids, for processing, is starting to convert, which is helping clean up some of that 80% salted butter, but it’s still not fast enough to really move the needle yet. Josh White: So, if the outlook for butterfat really doesn’t have any material upside in the near future, and we’re currently looking at Class III and IV prices, where they’re at, when do we start to impact the U.S. producer’s decision on making incremental milk beyond just the fat component? Are we close or are we still a long way away? Jacob Menge: Look at this Milk Production Report. We are up 268,000 head since June of 2024. That just keeps going up. There was an August revision of 71,000 head higher. The answer is a pretty [00:20:00] conclusive, not yet. I’m looking at the last time, September milk production beat the prior month, so beat August, which was 2001. And it just did that; September just beat August, and the last time it did that was 2001. Josh White: We’re not even talking about adjusted for components. Jacob Menge: That is correct. Joe Maixner: I can’t imagine that $16 to $17 Class III causes any worries right now for the farmers, with $4 corn and $1,200 feeder calves. Mike Brown: As long as you’re in a Class III market, if you’re heavy Class IV, your price isn’t $17. It depends on where you’re located, Joe. But for the most part, if you’re in a cheese market, it’s still decent. You’re right because the whey is also contributing a lot to that Class III price right now with a 70¢ whey market. Ted Jacoby III: Yeah. And the cows are all increasing in the states where there is increased processing capacity as well. Jacob Menge: These guys have had time to hedge this, and they still almost can hedge this, right? Going into later next year, where I think it’s gotta be at a point where they can’t hedge at a profit, and then you’ve [00:21:00] really got issues. Josh White: If we’re in a situation where the global economic outlook isn’t great, so that means we shouldn’t expect any major demand booms to pull dairy up We’re realizing supply growth in all major dairy surplus regions; the only correction for this is supply. And who’s the first to react? The obvious answer is it’s gonna be head-to-head with Europe and the U.S. Who breaks first? These are very, very different markets with different drivers, and they’re actually experiencing growth for different reasons related to the big picture, but different reasons. Europe just went through a situation where its butterfat carried the day. And butterfat was incredibly high, much higher than the U.S. price. They were an importer of fat from New Zealand, bringing in a noteworthy amount of product. And then now going into this year, they’ve seen a really significant drop, well below the support level that most traders would’ve held for butterfat. You assume [00:22:00] that they’re not gonna import a bunch of that product, forcing that product on the rest of the market. They’re going through a pretty negative situation right now as well. One thing you can’t forget about the European producer is that if you kill cows, it’s really tough to replace them, not for the same reasons we have in the U.S., that right now it’s just difficult to compete with beef. But they don’t wanna make those changes for a lot of regulatory reasons. So, they’re gonna hang on as long as possible. The U.S. model, we’re not in pain yet, generally speaking. Some smaller producers might look at higher beef prices and lower dairy outlook as an opportunity to exit. But there is way more structural expansion in motion or down the line that I think that train’s moving down the tracks. So, it’ll be really interesting to see if and who breaks first between the North American market and the European market. Ted Jacoby III: My hunch is it’s the U.S. market. I still think we’re a minimum of six months away, maybe even 12 to 18. Now there are signs, like you look at the Milk Production Report, the state of Washington is down [00:23:00] 8.5%. So, there are places where we are losing cows. Even though the majority of the country has gained cows recently, I would argue that with the drop in the butter price and the weakness in the nonfat market, California is the next one that I think will follow. They’ll struggle to get a decent milk price given that those are the two dominant price drivers for the California market. Diego Carvallo: But if you look at Idaho’s strongly up. So, it seems like a movement between Washington and Idaho. Ted Jacoby III: I think you could be right. Joe Maixner: California, their numbers this month were slightly higher than their peak production year 22. They’re on the uptrend. That’s a large ship that takes a while to turn around. Ted Jacoby III: I don’t disagree. I also think you’re still measuring against bird flu in California. You could argue that it may be a little artificially high. Joe Maixner: I actually questioned that because of the lower increase than I had anticipated for the September number, and bird flu didn’t actually start in California until October. So, we will see even larger increases next month forward in California. They [00:24:00] have that Class I plant that they opened as well out there. Mike Brown: They’re also getting hit with a big assessment, a lot of the producers out there, because the butter market changed, there’s been a lot of inventory loss, and that’s gonna hurt some producers as well. No one I talk to in California is worried about finding milk. They’re worried about finding a place to put it right now. Ted Jacoby III: I don’t think that’s isolated to being a California problem right now. Mike Brown: I would agree. You’re right. Ted Jacoby III: On that note, I think it’s a good time to wrap. Thanks, everybody, for joining us this week. Look forward to talking to you guys again soon. Thank you.

Musk ox are not something you see much of in the lower 48, but it's turned into a cottage industry for a farm in Palmer, Alaska. Bob Bosold visits with the farm education manager, Dani Biersticker at these unique animals, and the unique hair that turns into fabulous clothing.Heat definitely returns to Wisconsin this week. Stu Muck says we'll actually be above average on temperatures through at least Thursday.A livestock farm turned Christmas tree and maple syrup operation isn’t a story you hear everyday. In the late 90s, Dave Cook transitioned his family’s cattle and hog operation to a choose and cut christmas tree farm. Kiley Allan visits with Dave Cook, Owner and Operator of Cooks’ Woods. He tells her how he began making maple syrup and the success his business has seen from enrollment in the Something Special from Wisconsin program. Paid for by the Something Special from Wisconsin program.Markets are sluggish starting a Monday morning, pressured in part by a heightened harvest pace and big yields.Diesel hits big consumption on farms during the harvest. Jason Schwantz, senior vice president of energy at CHS, says plants have been retooling this summer leading to a smaller supply of diesel in the upper midwest. He's advising farms to think about securing their supplies now before other plants retool this fall.Dairy farmers had hoped that changes to the Federal Milk Marketing Orders would enhance their milk checks and their financial future. That may happen, but it's going to take time. Mike Brown, vice president for dairy market intelligence at T.C. Jacoby & Company, says early projections showed Class III milk prices could drop by as much as 90 cents per hundredweight, or about 7.5 cents per gallon. Some producers may have seen that, he notes, but many other factors, like processor-producer negotiations, continue to influence milk checks. Dairy operators should also prepare for the possibility of negotiation on their milk premiums. Stephane Hoff has the initial details.See omnystudio.com/listener for privacy information.

In this interview, URComped CEO, Craig Shacklett, sits down with Robert Christensen, Director of Digital Gaming at Choctaw Casino, for an in-depth look at the evolving world of online gaming through the lens of tribal operations. From the launch of Choctaw's Social Casino to the nuances of Class II versus Class III gaming, Christensen breaks down complex regulatory frameworks, the rise of sweepstakes and prediction markets, and Choctaw's strategic approach to digital gaming within sovereign tribal lands. The conversation also explores how European markets have influenced U.S. iGaming development, the growing tension between traditional and gray market operators, and how data-driven personalization is reshaping online player experiences.   Topics Discussed: Robert Christensen's Role Definitions & Distinctions in Online Gaming What are Social Casinos, Sweepstakes Casinos, iGaming, Prediction Markets, etc. and how are they different? Legal and Regulatory Landscape What are Class 2 games What is IGRA and how does it work What are compacts? Choctaw's Strategic Focus Expanding mobile gaming access beyond reservation boundaries Tribal Sovereignty & Class II Gaming European Influence & Technology Partnerships The Future of Online Gaming in the U.S. Barriers for iGaming development Casino Marketing: Digital vs. Brick-and-Mortar Responsible Gaming & Industry Ethics Learn more: https://trio360.vip/inside-tribal-igaming-choctaws-digital-strategy/

Federal Milk Marketing Orders set the rules for how milk is priced across the country, shaping returns for farmers, processors, and ultimately consumers. A historic update took effect June 1, and now that we’ve been under the revised system for a few months, what has it meant for Wisconsin’s dairy farmers? Mike Brown, vice president for dairy market intelligence at T.C. Jacoby & Company, says early projections showed Class III milk prices could drop by as much as 90 cents per hundredweight, or about 7.5 cents per gallon. Some producers may have seen that, he notes, but many other factors, like processor-producer negotiations, continue to influence milk checks. Regardless, Brown emphasizes the update was necessary. Looking ahead, he questions whether the Class III order will remain relevant given the strength of the cheese market, pointing out that growing demand for cheese and finding more value in whey, a byproduct of cheese, will be key to boosting returns for Class III dairy farmers. He also expects that negotiated contracts heading into the new year will help bring added premiums at the farm gate.See omnystudio.com/listener for privacy information.

The cheese and whey markets have been volatile due to their dependence on trade, and Mike Brown, vice president for dairy market intelligence at T.C. Jacoby & Company, says this is especially important for Wisconsin dairy farmers, since about 90 percent of the state’s milk goes into cheese. While the whey market behaves a little differently, he expects to see renewed investment in whey as Wisconsin continues producing award-winning cheeses. Brown notes that although the regulated minimum for Class III milk prices dropped with the Federal Milk Marketing Order update that took effect June 1, lower milk checks are also tied to other factors, including revenue declines for cheese processors.See omnystudio.com/listener for privacy information.

DAMIONThe next phase of Starbucks' turnaround plan is offering executives up to $6 million in stock grants, as baristas scrap to get annual raises above 2%Starbucks will reward company executives with up to $6 million in stock grants should they effectively fulfill cost-saving and timely rollout goals of the company's “Back to Starbucks” turnaround strategy. Starbucks Workers United representatives dubbed the move “ridiculous and irresponsible” amid contract negotiations over barista wages.WHO DO YOU BLAME?Double boomerang CEO and founder Howard Schultz1987-2000; 2008-2017; 2022-2023CEO and Chair Brian Niccol and his $113 million golden hello packageThe company's work-from-home policy which allows its CEO to work remotely from his home in Newport Beach, California, while the company's headquarters are in Seattle, Washington. As part of his employment agreement, Starbucks pays for him to travel between his home and the Seattle headquarters on the company's private jet.Former failure Yahoo! CEO Marissa Mayer who was appointed as a director to Starbucks 4 days before the announcement of the new retention awards. Compensation Committee chair Ritch Allison: The guy passes every pay plan for whoever; is the former CEO of Domino's Pizza so is here to enrich executives; and owns $3M is SBUX stock so doesn't really care: someone should be responsible for a CEO pay ratio of 6666:1Agios Appoints Dr. Jay Backstrom to Board of DirectorsJay Backstrom appointed as Class III director as of July 8, 2025, 20 days after the company held an election to appoint two Class III directors.WHO DO YOU BLAME?The top 4 institutional investors (35% of voting power):Farallon Capital 10% Vanguard 10%BlackRock 9% BB Biotech 6%The company's childish bylaws which separate directors into three classes that are voted on every three yearsFormer CEO Jacqualyn Fouse (23%) who stuck around to serve as board chair after being CEO for only 3 yearsNominating Committee chair and Lead independent director Kaye FosterEmasculated CEO Brian GOff (15%) who presides over a board with a +7% gender influence gapAn anti-DEI investment firm postponed its Tesla ETF, saying Elon Musk has 'gone too far' by launching a political partyWHO DO YOU BLAME?Its BS mission statement: “Azoria is an investment firm with the mission of compounding capital for investors through a commitment to free thinking, excellence, and meritocracy.”Wouldn't that include Elon?James T. Fishback, Founder and CEO of Azoria, a free-thinking investment firm“We have an anti-American subculture that cancels the science fair in favor of drag queen story hour, forces colleges to spend more time teaching micro-aggressions than microbiology, and teaches kids in America that Cardi B is a role model and Thomas Jefferson is a racist.”“Fishback will become a major Gen Z star in our pro-American movement.” — Vivek Ramaswamy, 2024 Presidential Candidate.“dropped out of Georgetown University to establish a hedge fund at 21 years old”Azoria partner Sol Ehrlich:“For my last day at Spectra, it's important that I share just how much this opportunity has meant to me. In June of 2023, I was a 28 year old mediocre Euro League baseball player with no job prospects outside of coaching. My only qualification to work in finance was my work ethic, which Brent Donnelly recognized when he met with me over Zoom and saw the litany of Post-It tabs I used to annotate his book”“It's with great excitement that I'll be taking this skillset to Azoria as a partner and its Head Trader- an opportunity I couldn't have imagined 18 months ago.”While the internet was introduced to James Fishback's talents this year, I've been aware of them since 2009 when we competed against each other in high school debate. (His meme game was A+ even then- I still remember him closing a speech on U.S. sanctions with 4 Russian leader puns.)”Me. Because somehow I'm connected to Fishback on linkedin.Greenlight Capital, for making James angry:In a lawsuit: “Greenlight Capital says James Fishback is a liar. The 29-year-old hedge fund manager and former employee, contrary to his own proclamations, was never “head of macro” at Greenlight, never had any “authority or discretion” over investments, and certainly wasn't responsible for an “insane” $100 million in profits as a mere research analyst. In fact, his contributions were so not “insane” that the hedge fund was about to fire him before he chose to leave of his own accord.”Greenlight's alleged former head of macro is hoping to get at least $5 million from David Einhorn, claiming age discrimination"Mr. Einhorn dismissively told Mr. Fishback that his compensation was 'a lot of money for a kid,'" the filing states, and Fishback argues the comment "demonstrates that Defendants' decision about Mr. Fishback's compensation was driven largely by his age — a protected characteristic."Tech founders call on Sequoia Capital to denounce VC Shaun Maguire's Mamdani commentsMaguire, an outspoken supporter of President Trump, posted on X over the weekend that Democratic mayoral candidate Zohran Mamdani “comes from a culture that lies about everything.”WHO DO YOU BLAME?Shaun Maguire: “My whole life I've sought out people that I think are really talented but a little bit off the radar.”Shaun Maguire: “[E]ven more important to me is someone that's just irrationally motivated. For whatever reason, it's their life mission to try to revolutionize the industry they're going after.”Shaun Maguire: “Should I go public with the story about the time I was told I can't be promoted for being a white man? Fuck it, This happened at Google. That company is an absolute trash can dumspeter fire.”Sequoia Capital: for proudly endorsing some of its most insipid founders: Sam Altman, Elon Musk, Vlad Tenev (Robinhood, online betting on stocks), Keller Rinaudo (Zipline, autonomous delivery), Winston Weinberg (Harvey, AI for lawfirms), Brian Chesky (Airbnb, rent killer)MATTForward Air, after their AGM battle with Ancora, still hasn't released their 8K after a MONTH despite Ancora announcing it was a “landslide” directly afterWHO DO YOU BLAME for not releasing an 8k?Charles Anderson, Robert Edwards Jr, Michael Hodge who own roughly 25% of the voting power, even if FF data doesn't properly show them as having all the influence on the boardAncora, who just couldn't help but IMMEDIATELY put out a press release stating: “Absent the more than 30% of shares that were legally committed to vote for the incumbent Board, Chairman George Mayes, Jr., Javier Polit, and Laurie Tucker lost in a landslide, highlighting the substantial level of concern regarding the legitimacy of the Board's strategic review. We believe the resignations of these legacy directors will empower the Board to carry out a thorough assessment of value-maximizing opportunities.”Christine Gorjanc, chair of the audit committee, who was chair of the audit committee at Invitae from 2015 to 2024 when it declared bankruptcy despite getting her degree in accounting and a MS in “taxation”Michael L. Hance, chief counsel who also holds a masters in Divinity, who couldn't find the “submit” button on his iPhoneNo, Carnival Cruises is not banning rap musicCarnival Cruise Lines denied reports circulating online that DJs aren't playing hip-hop.The cruise line has responded to claims circulating online that DJs aren't including hip-hop music in their sets or honoring song requests, with some social media users saying the alleged move is racially motivated.WHO DO YOU BLAME for this malicious rumor?Carnival's ZERO BLACK leadership team, lead by Mickey Arison - they do have two Hispanic men, Enrique Miguez (General Counsel) and Gustavo Antorcha (President of Princess Cruises), but it's balanced out by the Scandinavian (Lars Ljoen, Chief Maritime Officer) and other Euro men (Felix Eichhorn, Paul Ludlow)Carnival's Board of Directors, which has 11 members and is 91% white, with one black woman, Nelda Connors. Nelda's background is in hydraulics and metals with a degree in mechanical engineering, so she's probably too “nerdy” for rap anywayChristine Duffy, the head of Carnival Cruises, whose prior role was President of the Cruise Lines International Association which put out a report in 2008 showing that 93% of cruise passengers were white, and in 2025 said that 1 in 4 passengers came from either Texas or Florida. Duffy grew up in Northwood Philadelphia, which in 1950 was three quarters white but by 2020 is 93% black.Thinking hip hop is “black music”DAMIONPeople are boycotting Etsy over ‘Alligator Alcatraz' merchCalls to boycott Etsy are growing since “Alligator Alcatraz” merch popped up on its marketplace. The term refers to the Trump administration's new migrant detention facility in the Florida Everglades.WHO DO YOU BLAME?The 48% influence duo: CEO Josh Silverman (25%) and longest-tenured director (2007): Board Chair and Nominating Committee chair Fred Wilson (23%)The -13% gender influence gap at a company where: “approximately 80% of Etsy's buyers and sellers are women.Leadership is 6 men and 2 women, one of who is CHROThe company's dumb classified board structureThis year's 3 directors: 24%, 28%, 22% againstTokens to Access Private Companies, or to Investor Trouble?Robinhood is the latest to offer investors a novel, and potentially risky, investment opportunity: crypto that's meant to give exposure to the likes of OpenAI.WHO DO YOU BLAME?CEO/founder/Chair Vladimir Tenev: 47% influence; 24% voting power Baiju Bhatt: 37% influence; 36% voting powerThe pesky Class B share: for being worth ten votes per shareThe non-democratic Founders' Voting Agreement: Our Co-Founders have agreed: “to vote all of their shares in favor of the election of each Co-Founder”Lead Independent Director Jonathan Rubinstein: for being the most pointless Lead Independent Director of all time: Lead Independent Director at Robinhood since 2021 and Lead Independent Director at Amazon.com from 2017-2023OpenAI Says It's Hired a Forensic Psychiatrist as Its Users Keep Sliding Into Mental Health Crises"We're developing ways to scientifically measure how ChatGPT's behavior might affect people emotionally."WHO DO YOU BLAME?Sam AltmanBret Taylor (Chair)Sam AltmanMatt: AI itself for being a jerk

This podcast is the audio version of the Gear Garage Live Show, where we answer submitted questions and talk all things whitewater. Today's Show! Answer Questions Middle Fork Beta Some of the Questions that Zach covered in the Q&A section of this episode Topic: Rope! Say I'd like to put together something I hope I never need. I have some gear, but I'm wondering what kind of rope you would recommend for a Pin kit. I know you guys are swamped this time of year, so no worries if you don't respond. Topic: Blower Adaptor Any beta on if the Makita or Milwaukee adaptor fits the cheap K. I. M. O leaf blower? I'm bleeding money on raft gear, Trying to save where I can. Topic: Two Rowing Questions I'm a complete newbie, trying to understand some of the major dos and don'ts as I gain entry-level experience rowing a raft. I've heard two things from multiple people, and I'd love to get your take: “Never exceed 45 degrees to the current” I understand how this can be safe advice for a beginner, but obviously, there are times you need to break this rule for certain maneuvers. Are there situations where being 90 degrees to the current is okay, and others where it's a definite no? I get that if there's an object downstream, the last thing you want is to hit it broadside — so staying at 45 degrees makes it more likely you'll hit bow-first instead of getting hung up sideways. But in your videos, I see a lot of ferrying at greater than 45 degrees or even rowing at 90 degrees to the current. When you're 90 degrees to the current, is there concern that water hitting the upstream side of the raft could flip it? Flipping at eddy lines I've heard a few horror stories of people flipping when they hit eddy lines — no rocks, no holes, just a fast eddy line that flipped them. But in your videos, you show catching eddies by pushing and pulling, and it always looks smooth. What would someone have to do wrong to flip in that situation instead of catching the eddy cleanly, like you do? The stories I've heard don't involve getting pinned or hitting an obstacle — just the eddy line itself. And honestly, the eddy lines you cross in your videos look just as strong or stronger than what they're describing. Thanks for your time — I know that's a lot to unpack! Topic: Used Rafts? I did a trip with you a couple years ago down the Rogue River and loved it. I live up in Roseburg and am trying to find a used raft and oar rig setup. I'd like to do your Class III training trip next summer. I'm curious if you have any rafts that you're looking to get rid of? I live on the Umpqua River and would like to start rafting it and learning.

Welcome to Teeth & Titanium, Episode 56, “Live from ICOMS 2025 Singapore” This episode features: Current Events-   ICOMS Singapore Guest Interviews-   Dr. Eppo Wolvius (Netherlands)-   Dr. Chee Weng Yong (Singapore) Journal Club with Dr. Chee Wang Yong-    Panoptic evaluation of maxillomandibular stability and quality of life after surgery-first approach versus conventional three-stage method in skeletal Class III orthognathic surgery—systematic review and meta-analysis Audience Questions/T&T Debate Club            - AI Transcribing             - Bringing family to conferences Resident reminder            - If you could give one tip to a resident/trainee what would it be Or what you would advise your             resident/trainee self if you could go back International correspondent audition  Recommendations with Special Guest Dr. Daisy Chemaly President of CAOMS            - Attending Conferences            - Changing focus            - Oscar or Wendall? Be sure to subscribe so you never miss an episode! Apple / Spotify / Google / Online links Thanks to the CAOMS/ICOMS for their continued support of this podcast. https://www.caoms.com.  If you would like to contact us, be a guest, or would like to submit a topic for Resident Reminder or Journal club, please email us at: teethandtitaniumOMFS@gmail.com Hosted by Dr. Wendall MascarenhasProduced by Dr. Brad W. Ray Articles/Books cited in this episode: Jenwanichkul N, Keerativittayanun S, Suttapreyasri S, Pripatnanont P. Panoptic evaluation of maxillomandibular stability and quality of life after surgery-first approach versus conventional three-stage method in skeletal Class III orthognathic surgery-systematic review and meta-analysis. Int J Oral Maxillofac Surg. 2025 May 13:S0901-5027(25)00116-X.

The Lancet Volume 353, Issue 9146 p9-13 January 02, 1999Background: Accumulating data at the time suggested functional benefits of antagonism of beta-adrenoreceptors in patients with heart failure. Multiple specific beta-blockers were being tested in trials. The CIBIS 1 trial found a trend towards 20% lower mortality in the bisoprolol (a highly cardio-selective beta-blocker) group and 30% fewer admissions to hospital for worsening heart failure. The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II) trial was designed to test this evidence further.Patients Eligible patients had New York Heart Association Class III-IV symptoms with LVEF ≤ 35% and were stable on diuretics and ACE-inhibitors. Exclusion criteria included recent MI or coronary intervention, AV block or resting heart rate less 60 bpm and systolic BP < 100 mmHg. Patients already on beta-blockers or with planned therapy with beta-blockers were also not enrolled.Cardiology Trial's remains independent, free of industry ads, due to reader generosity. Please consider becoming a free or paid subscriber.Baseline Characteristics The mean age of patients was 61 years, 81% male, and 83% Class III. The mean LVEF was 28%. About half the patients had ischemic heart disease, 12% primary dilated cardiomyopathy and nearly 40% had a mixture of valvular heart disease, hypertensive heart disease or unproven ischemic disease.The mean SBP on enrollment was 130 mmHg and resting HR was 80 bpm. The mean duration of heart failure before enrollment was 3.5 years. About 20% had AF at baseline. Nearly all patients were on ACE-I and half were on digoxin.Trial Procedures There was no run-in period. CIBIS II was double blinded. Slightly more than 2,600 patients were randomized 1:1 to bisoprolol or placebo in 274 hospitals across 18 countries.Patients in the bisoprolol group were started at 1.25 mg daily and titrated up weekly to as high as 10 mg daily. The goal was to attempt the highest tolerated dose. Patients were seen every 3 months.Endpoints The primary endpoint was all-cause mortality. Secondary endpoints included all-cause hospital admissions, cardiovascular mortality, combined CV death and CV hospital admissions, and premature treatment withdrawals.The authors estimated a 11.2% mortality in the placebo group and powered the trial to find a 25% reduction in death in the bisoprolol arm over 2 years.Results The trial was sopped early (mean follow-up 1.3 years) after the planned second interim analysis for benefit. The primary outcome of all-cause death occurred in 11.8% in the bisoprolol group vs 17.3% in the placebo arm (HR 0.66 (95% CI 0.54-0.81, p < 0.0001)).Bisoprolol reduced sudden death (3.6% vs 6.3%), all-cause hospitalization (33% vs 39%), CV death (9% vs 12%). Permanent treatment withdrawal occurred in 15% of both arms.The subgroup analysis showed no substantial treatment heterogeneity. The most common dose was 10 mg daily reached in 43% of patients.Conclusion The 34% reduction in death was clinically meaningful and statistically robust. Our confidence in such a large effect size stems from a) previous data on beta-blockers, which found similar effects, b) the 42% reduction in sudden death in the bisoprolol arm and c) the large reductions in all-cause hospitalization. In addition, the trial conduct appeared strong with almost no lost-to-follow up. The lack of run-in period strengthens the external validity of CIBIS II.The same caveats seen in the US carvedilol trial also apply to CIBIS II, namely that patients were ambulatory, outpatients, mostly with Class III symptoms. Patients enrolled in the trial had a mean SBP of 130 mmHg and a resting heart rate of 80. Nearly all patients were tolerating ACE-I and half were taking digoxin. In addition, patients were started on low-dose and gradually titrated higher. The majority of patients were on higher than 5 mg daily.The authors warned against applying these results to non-ambulatory patients with Class IV symptoms, especially if there was recent instability. Get full access to Cardiology Trial's Substack at cardiologytrials.substack.com/subscribe

In this week's episode of The Milk Check, the Jacoby team convenes to dissect a dairy market that feels balanced – barely. From milk still trickling in past the flush to range-bound commodity prices, this episode covers the major trends shaping the back half of 2025. Cheese exports are keeping Class III in check Culling numbers are down as producers are keeping heifers longer Global butterfat advantage fading with tighter GDT spreads WPC, WPI demand stable, but new production capacity looms And what if prices fall off the edge? From trade risks to recession fears, the industry feels one light push from price chaos. Listen now for insights on margins, milk flows and market forces. Got questions? Got questions for The Milk Check team? We've got answers. Submit your questions below and we'd be happy to get back to you or answer your question on the podcast. Ask The Milk Check Intro (with music): Welcome to The Milk Check, a podcast from TC Jacoby & Co., where we share market insights and analysis with dairy farmers in mind. Ted Jacoby III: Hello everybody, and welcome to this month's version of The Milk Check podcast by TC Jacoby & Co. This week, we will have a classic market discussion. It is June 9th, so we're approaching the midpoint in the month of June 2025, and joining me today are Diego Carvallo, our Director of Dry Dairy Ingredients Trading. Jacob Menge is our vice president of risk management and trading strategy. Josh White, our Vice President of Dairy Ingredients. Mike Brown, our VP of Market Intelligence. Joe Maixner, our director of dairy ingredients and resident butter expert, is also there. I think we'll go ahead and start with milk. It's the middle of June. We're past the flush, but milk is probably a little bit heavier than we expected. Milk production has been up. We know what is going on. The dairy farmers are making money, and they're keeping cows. Their culling numbers are down, and so we're seeing cow numbers up, maybe a little bit surprisingly, given what we know about the heifer replacement numbers, which means they're keeping them for an extra lactation, that is keeping milk solids output maybe a little bit lower than we expected. But the solids are still up as well. So as a result, we're seeing milk still on the long side, not too much out of what is normal for this time of year, and I wouldn't be surprised as the weather in the upper Midwest starts to heat up, we start to see that milk production drop off a little bit and everything get a little bit tighter. We just haven't quite reached that high temperature yet. And so that's what we're seeing in milk. Jake, how does that translate into cheese? What are we seeing in the cheese market right now? Jacob Menge: It's funny, I think from the last time we had a market discussion to today, the message will be very similar, which is a lot of mixed signals on the cheese side. You can talk to certain people who say, Hey, our orders are way down. And then you might talk to somebody else, saying, Hey, our orders look pretty good, meaning the demand is there. I think it's a bit of a tale of two cities regarding how exposed you are to the export market. Exports have been the thing that has been keeping us afloat on the cheese side. I think domestically, we're not doing great. I would say that the prices that we've been seeing, this kind of upper 190s, mid to upper 190s, we've come off in the past week or two, but I think that mid to upper 190s did hurt demand on the export side. I think that's kind of where we're at. I would say good, not great. It just seems like we're going to be range bound a bit on the cheese market just given this kind of pendulum swing of our prices move too high, which kills exports a little bit, but if we go down even just a little bit, you think the export market comes back in, so that's the feel we've got right now. Ted Jacoby III:

Why a Single Ad Formula Falls Short When two veteran growth agencies—HIP Creative and Neon Canvas—compare notes and still disagree about whether Facebook or Google deserves the first marketing dollar, it's clear the universal-playbook myth needs to die. As Dr. Kyle Fagala observes, a Class II malocclusion isn't treated exactly like a Class III—so why […] The post The $4,500 Question: Meta vs Google Ads appeared first on HIP Creative.

Lancet 1999;353:2001-07Background: Beta-blockers directly reduce cardiac contractility and myocardial oxygen demand. For decades, they were avoided in patients with acute and chronic heart failure over concerns they would facilitate decompensation of the condition. The therapeutic cornerstones of treatment, prior to the modern era of clinical trials, focused on managing symptoms and quality of life with diuretics and inotropic agents like digoxin; however, new paradigms were arising that focused on addressing neurohormonal mechanisms of chronic disease that were over-activated in the failing heart. The first major success came with inhibition of the renin angiotensin aldosterone system with angiotensin converting enzyme inhibitors whose effect on mortality for patients with mild and severe forms of chronic heart failure were demonstrated in the V-HEFT II, CONSENSUS, and SOLVD trials. Additional benefits were demonstrated with the mineralocorticoid receptor antagonist spironolactone in the RALES trial. These drug classes primarily work by reducing afterload and volume retention. Appreciating why they work for improving cardiac performance and managing symptoms in heart failure patients is straightforward when we consider the major factors that effect cardiac stroke volume - preload, afterload and contractility; however, it is also noteworthy the effects these agents have on sudden death. How beta-blockade benefits the failing heart is less obvious (outside prevention of sudden death). Mechanistic studies in patients with chronic heart failure have consistently shown that when beta blockers are used for more than 1 month, left ventricular function improves. Beta blocker therapy appears to restore the density of beta-adrenergic receptors after they have been downregulated by the chronic overactivity of the sympathetic nervous system. The first major placebo-controlled RCT to demonstrate a mortality benefit used the non-selective beta blocker carvedilol. The trial was small and not originally designed to test mortality and was stopped early without clearly predefined stopping rules. Furthermore, 8% of total patients selected for participation in the trial were excluded prior to randomization after a 2 week, open-label run-in phase with the study drug, which saw 2% of all patients experience worsening heart failure or death representing 24 patients (the difference in total deaths between groups was 9 when the trial was stopped). The Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF) was the first large scale trial designed to test the hypothesis that beta-blockade with metoprolol controlled/extended release (CR/XL) added to optimum medical therapy reduces mortality in patients with chronic systolic heart failure.Patients: Patients were recruited from 313 sites in 13 European countries and the United States. Eligible patients were men and women between the age of 40 to 80 years with symptomatic heart failure (NYHA class II-IV) for >/= 3 months before randomization. They had to be on a diuretic and ACE inhibitor for at least 2 weeks. Other drugs, including digoxin, could also be used. Patients also had to have an EF of /=68 beats per minute.Patients were excluded if: they had an MI or unstable angina within 28 days; had an indication or contraindication for treatment with beta-blocker; beta blockade within 6 weeks; heart failure due to systemic disease (i.e., amyloidosis) or alcohol abuse; scheduled or performed cardiac transplant; an ICD; procedures such as CABG or PCI planned or performed in the past 4 months; 2nd or 3rd degree AV block unless a pacemaker was present; unstable or decompensated heart failure defined by pulmonary edema or hypoperfusion or supine systolic BP 25% deviation of the number of observed versus expected consumed placebo tablets during the run-in period.Baseline characteristics: The mean age of patients was 64 years and approximately 78% were male. Slightly more than 30% of patients were above the age of 70. The average EF was 28%. The average SBP was 130 mmHg and heart rate was 82 bpm. Most patients had mild to moderate heart failure, with 41% in NYHA Class II, 56% in Class III, and only 3% in Class IV. Ischemic cardiomyopathy accounted for 65% of cases and nonischemic causes accounted for 35%. Most patients were on an ACE inhibitor or ARB (95%) and diuretic (90%). Digoxin was used in 63%. Trial procedures: Prior to randomization, the study was preceded by a single-blind, 2-week placebo run-in period. Patients meeting eligibility were then randomized to placebo or metoprolol CR/XL. The starting dose of placebo or metoprolol CR/XL was 12.5 mg daily for patients in NYHA class III or IV and 25 mg daily for patients in NYHA class II. The dose was doubled every 2 weeks until the target dose of 200 mg daily was reached. Patients were followed every 3 months.Endpoints: The primary outcome was all-cause mortality. It was estimated that 3,200 patients would need to be followed for 2.4 years to detect a 30% relative reduction in mortality based on annual mortality rate of 9.4% in the placebo group. This would achieve at least 80% power with a 2-sided alpha of 0.04. Patients were recruited faster then planned and so the final sample size of 3,991 patients increased the power of the study.The study was monitored by an independent safety committee and predefined stopping rules for efficacy were based on all-cause mortality, done when 25%, 50%, and 75% of expected deaths had occurred. Results: The trial was stopped early after the 2nd preplanned interim analysis when 50% of expected deaths had occurred. The mean duration of follow-up at the time of stopping was 1 year. The mean daily dose of metoprolol CR/XL was 159 mg once daily, with 87% receiving 100 mg or more and 64% receiving the target dose of 200 mg daily. In the placebo group, the corresponding values were 179 mg daily, 91% and 82%. The study drug was discontinued permanently in 14% of patients in the metoprolol group and 15% in the placebo group. Six months after randomization, heart rate decreased by 14 bpm in the metoprolol group compared to only 3 bpm in the placebo group. Systolic blood pressure decreased less in the metoprolol group (-2.1 vs 3.5 mmHg).Compared to placebo, metoprolol significantly reduced all-cause mortality (7.3% vs 10.8%; RR 0.66; 95% CI 0.53—0.81). Cardiovascular mortality accounted for 91% of all deaths; with sudden death accounting for 58% and death from worsening heart failure accounting for 24% of all deaths. All 3 of these causes of death were significantly reduced by metoprolol. The relative and absolute effects on death were greatest for patients with NYHA class III heart failure.Conclusions: In this trial of stable patients with mild to moderate chronic systolic heart failure, who were optimized on an ACEi or ARB and diuretic, metoprolol CR/XL significantly reduced all-cause mortality. Approximately 30 patients would need to be treated with metoprolol compared to placebo for 1 year to prevent 1 death. This trial represents a significant win for beta blockade in patients with chronic systolic heart failure. While the NNT in this trial is slightly higher than in SOLVD, it is important to appreciate that follow-up time in SOLVD was more than 3x longer. Limitations to external validity in this trial include the run-in period and stringent inclusion and exclusion criteria. Our enthusiasm is also tempered by early stopping, which has been found to be associated with false positive or exaggerated results but this concern is mitigated to some extent in this trial because the rules for early stopping were clearly defined in the protocol.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support our work, consider becoming a free or paid subscriber. Get full access to Cardiology Trial's Substack at cardiologytrials.substack.com/subscribe

Halei Heinzel is getting ready to learn who the next Alice in Dairyland will be. The final phases of interviews begin today in Crawford County. Jill Welke talks with Heinzel about her year-long experience and what memories she'll be taking away when she departs officially in July. Severe weather is on the way for a good chunk of Wisconsin today. Stu Muck draws the lines where heavy weather's expected.Stephanie Hoff introduces us to another one of the six finalists for the Alice position. Natalie Roe from Monticello first found out about the Alice program when the selection process came to Green County. She says her love of agriculture's been apparent since she was a little girl. Ben Jarboe gets in a quick conversation with the incoming executive director of the Wisconsin Farmers Union in Chippewa Falls. Danielle Endvick grew up in agriculture and previously served as communications coordinator for WFU. She shares some of the priorities she's bringing to the post. Keep an eye on the cheese market. Beginning next week, barrel cheese essentially "goes away" in Chicago and the Class III pricing formula. That's according to Matt Tranel, dairy analyst with EverAg. He joins Pam Jahnke for the discussion.See omnystudio.com/listener for privacy information.

N Engl J Med 1996;334:1349-1355Background Before 1990, the prevailing idea held that the negative inotropy of beta-blockers would harm patients with impaired systolic function. Yet part of the progression of systolic heart failure involved over stimulation of the sympathetic nervous system. Norepinephrine can exert adverse effects on the circulation, both directly and indirectly. Smaller trials of beta-blockers in systolic heart failure found trends for benefit with beta-blockers, however, a mortality benefit had not yet been proven. The U.S. Carvedilol Heart Failure Study aimed to study mortality in patients with heart failure with a reduced ejection fraction.Cardiology Trial's Substack remains free of industry ads because of your support. Thank you. Please consider becoming a free or paid subscriber.Patients The study enrolled 1094 patients with chronic heart failure symptoms for at least 3 months, LVEF ≤ 0.35%, at least 2 months of treatment with diuretics and an angiotensin-converting enzyme (ACE) inhibitor (if tolerated). Treatment with digoxin, hydralazine, or nitrates was permitted but not required.Exclusion criteria were extensive and important to understand. These included any recent major cardiac events or surgery within the previous 3 months, uncorrected valvular disease, active myocarditis, sustained VT or higher degrees of AV block not controlled by pacing, systolic blood pressure of more than 160 or less than 85 mm Hg or diastolic blood pressure of more than 100 mm Hg, clinically significant kidney or liver disease or use of calcium-channel blockers, adrenergic agonists/antagonists, or class IC/III antiarrhythmic agents. Patients receiving β-adrenergic agonists or antagonists (presumably for another indication) were not enrolled.Baseline Characteristics The results of this and other beta-blocker trials in heart failure will be clear. One of the most important points for translating this evidence to patients will be the baseline characteristics. It is vital to understand who these patients were.The mean age was 58 years and approximately 76% were male. Most patients had mild to moderate heart failure, with 53% in NYHA Class II, 44% in Class III, and only 3% in Class IV. The etiology of heart failure was nearly evenly split between coronary artery disease (47%) and nonischemic cardiomyopathy (53%). Patients had significantly impaired cardiac function with a mean LVEF of 0.23. The mean six-minute walk distance ranged from 386 to 390 meters. Hemodynamic parameters were relatively stable, with mean systolic blood pressure of 116 mmHg, and mean heart rate of 83-84 beats per minute. Most patients were receiving standard heart failure therapy at baseline, including digitalis (90-91%), loop diuretics (95%), and ACE inhibitors (95%), while approximately one-third (32%) were on direct-acting vasodilators.Trial Procedures Patients were assessed for eligibility during a 3-week screening period during which exercise capacity was assessed with a 6-minute walk test. Notable was that these were outpatients able to complete a 6-minute walk test. Enrollment was stratified to one of four treatment protocols on the basis of the patients' performance on the exercise test: patients able to walk between 426 and 550 m when tested were assigned to the mild-heart-failure protocol; those able to walk between 150 and 425 m were assigned either to the moderate-heart-failure protocol or to a dose-ranging protocol, depending on the location of the study center; and those able to walk only less than 150 m were assigned to the severe-heart-failure protocol.After this base-line testing, all patients received 6.25mg of carvedilol twice daily for two weeks in an open-label run-in period. Those who tolerated this initial dose were then randomized to receive either placebo (n=398) or carvedilol (n=696) on a double-blind basis, in addition to their usual medications.The allocation ratio (carvedilol:placebo) was 2:1 in the mild and severe heart failure protocols and 1:1 in the moderate heart failure protocol. The dose was gradually increased to target levels of 25-50mg twice daily over 2-10 weeks, followed by maintenance therapy for an additional 6 months (12 months for mild heart failure).Endpoints At the time of trial planning, the original intent was safety. That is, to show that carvedilol did not increase mortality. The original intent was to enroll 1100 patients. As smaller trials on beta-blockers were published, the statistical plan included the possibility of beta-blocker benefit. The trialists therefore planned two sided statistical analysis.Cumulative survival curves were constructed as time-to-first-event plots by Kaplan–Meier survivorship methods and differences between the curves were tested for significance by the log-rank statistic with use of a Cox proportional-hazards regression model (which included the protocol as a covariate).Results Median follow-up was only 6.5 months due to early termination for benefit. The patients mean total daily dose of carvedilol was 45±27 mg. Overall mortality was 7.8% in the placebo group vs. 3.2% in carvedilol group. The relative risk reduction from carvedilol vs placebo was 65% (95% CI, 39-80%; p

In Part 1 of this two-part series, Etienne Nichols sits down with regulatory strategist Dr. Mike Drues to explore the nuanced differences between prescription (Rx) and over-the-counter (OTC) medical devices. They demystify key terms, regulatory classifications, and the growing trend of label expansions from Rx to OTC—highlighting real-world examples like CPAP machines and continuous glucose monitors (CGMs). This episode unpacks how intended users, environments, and risk tolerances shape device categorization, and why usability testing is far more complex than many realize. Whether you're developing a consumer health product or preparing a label expansion strategy, this is a must-listen for your regulatory roadmap.Key Timestamps[03:05] – What defines an OTC vs. prescription medical device?[06:45] – Market size of OTC devices and major product categories10:00 – Label expansion: moving from Rx to OTC status13:22 – The role of intended use environment in OTC classifications20:40 – Examples of devices in each FDA class that are OTC26:30 – Prescription devices used in home settings vs. true OTC31:15 – Characteristics that qualify devices for OTC status37:55 – Self-diagnosis, self-selection, and patient usability challenges43:00 – “Reasonably foreseeable misuse” and how to interpret guidance49:05 – Do you design for the lowest common denominator?56:10 – Representing diverse user populations in usability testing1:01:45 – Can a device launch OTC first? The case for wellness-to-Rx strategies1:08:15 – FDA's perspective on device safety: OTC vs. RxQuotes“The best regulatory professionals don't just know the rules—they know the exceptions.”Dr. Mike Drues reminds us that exceptional regulatory strategy lies in understanding nuance, especially in OTC classifications where edge cases can redefine categories.“Just because a device is used at home doesn't mean it's over the counter.”This insight challenges a common industry assumption, underscoring the importance of carefully defining intended use and environment early in development.Key TakeawaysOTC ≠ Low Risk by Default – Many Class II and even rare Class III devices can be OTC; it's more about intended user, use environment, and risk mitigation than class alone.Label Expansion Requires Strategy – Transitioning a device from prescription to OTC isn't just about removing a doctor's role—it may involve new usability studies, labeling changes, and potentially a 510(k) or de novo submission.Understand the "Intended Use Environment" – FDA doesn't just care about where the device is used, but how those environmental parameters (like light, humidity, and user training) affect safe operation.Usability Testing Must Reflect Real Users – For OTC devices, human factors validation must account for diverse educational backgrounds, not just ideal users.Don't Rely on Labels Alone – Whether or not users read (or understand) instructions must be tested, not assumed. Intuitive design is critical for OTC success.References & ResourcesEtienne Nichols on LinkedInGreenlight Guru Medical Device Classification Webinar with Mike Drues (for explanation on device classes)FDA Guidance: “Factors to Consider When Making Benefit-Risk Determinations in Medical Device...

Are you new to the medical device industry—or mentoring someone who is? In this foundational episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Sara Adams and Chris Rush from Greenlight Guru to deliver a MedTech 101 masterclass. They unpack the roles, regulations, and realities of medical device development in a heavily regulated space. From defining what actually counts as a medical device to navigating FDA classifications and global regulations, the trio offers practical insights, industry analogies, and personal war stories that make this episode as entertaining as it is educational. Whether you're in R&D, marketing, clinical, or quality, this is the episode to bookmark and share with every new hire.Key Timestamps02:20 – What counts as a medical device? Intended use and labeling06:48 – Differentiating roles: Quality, Regulatory, Clinical, R&D, and Marketing15:40 – Understanding regulatory bodies: FDA, EU MDR, Health Canada, and more20:15 – FDA Classifications: Class I, II, III, and what determines risk26:00 – Standards to know: ISO 13485, 14971, 14155, 21 CFR Part 82033:05 – FDA pathways: 510(k), De Novo, PMA – when and why they apply41:55 – The design control matrix explained (User Needs through Validation)49:00 – Reverse engineering design controls: pitfalls and best practices55:30 – Clinical trials vs. preclinical studies: When each is required1:00:45 – Manufacturing & supplier controls: operations meets compliance1:04:15 – Final advice for MedTech newcomers: Read the regs and know the problemQuotes“Just because you don't call it a medical device doesn't mean the FDA agrees with you.” – Sarah AdamsThis quote highlights a key regulatory pitfall: your marketing claims, not just your label, determine if the FDA considers your product a medical device.“A 510(k) is like someone checking your wristband at the door—you're cleared to go in. A PMA? That's a locked door and you need full approval to enter.” – Chris RushA memorable analogy that demystifies the difference between FDA clearance and approval pathways.Top TakeawaysLabeling + Intended Use = Regulatory TriggerWhether it's software or a simple tool, if your product makes medical claims or supports medical decision-making, it may fall under FDA or other international regulatory oversight.Regulatory Pathways Are Tied to Risk and NoveltyKnow the difference between a 510(k), De Novo, and PMA. Class II “me-too” devices may avoid clinical trials, while Class III and novel devices usually require significant evidence.Understand Design Controls EarlyReverse-engineering documentation late in development is risky and inefficient. Start early with user needs and build forward through the five pillars: inputs, outputs, verification, and validation.Cross-functional Understanding Prevents Compliance GapsMarketing, clinical, and R&D all influence regulatory standing. Even social media likes can trigger off-label scrutiny—every department needs to understand their regulatory impact.Reading Regulations Is Not OptionalA strong regulatory foundation is key to faster development, better audits, and smoother market access. Resources like 21 CFR Part 820 and ISO 13485 are surprisingly readable and essential.References & ResourcesEtienne Nichols on LinkedInChris Rush on LinkedIn

As we hit the quarter-century mark in agriculture and ag lending, there’s a tale of two economies unfolding. According to Dr. David Kohl from Virginia Tech’s Department of Agriculture and Applied Economics, the U.S. economy is holding strong, but the global economy is facing headwinds. Stu Muck tells us what rainfall could look like around the state this evening and into the Easter weekend. Spring is the time for bunnies and baby chicks. It's fur and feather swap season at a town near you. In Walworth County, they're gearing up for a swap to help fund the Fur & Feather Sale at the county fair and several scholarships for youth exhibitors. Dr. Temple Grandin tells Ben Jarboe that if you get down and see what an animal sees, then you can better understand their behaviors. At a UW-Madison event, she tells Mid-West Farm Report about key moments in her career that have led her to new animal welfare research today. Ever.Ag dairy analyst and broker Cody Koster joins Mid-West Farm Report with an explanation for the Class III rally. He says, despite the tariff scare, countries can't argue that U.S. dairy products are the cheapest in town, spurring an increase in export numbers, aided by a weaker U.S. dollar. Exports are critical to eating up the domestic supply.See omnystudio.com/listener for privacy information.

In this episode of The Milk Check, find out why some dairy producers may be eyeing the exit. Sarina Sharp, risk manager at Ag Business Solutions and the writer behind TC Jacoby's Weekly Market Report joins the Jacoby team this week. Sarina brings invaluable insights as we dig into critical topics like: Milk prices and financial stability: How long can dairy farmers survive with Class III prices dipping below $17? Supply chain shifts: How whiplash tariffs, changing federal orders, and fluctuating demand are affecting the U.S. dairy market. Bird flu and milk production: How the bird flu has changed U.S. milk production, and where it may strike next. Tune in to The Milk Check episode 75: Exit stage left: Why some producers are selling out while they can. If you like milk (and we know you do), then pour yourself a mug and tune in for insights on how to navigate this uncertain landscape and stay ahead in the coming months. Special Guest: Sarina Sharp, risk manager, Ag Business Solutions, and market analyst for the Daily Dairy Report The Jacoby Team: Josh White, vice president, dairy ingredients Ted Jacoby III, CEO & president, cheese, butter & dry ingredients Mike Brown, vice president, dairy market intelligence Gus Jacoby, president, fluid dairy ingredients & dairy support Intro (with music): Welcome to The Milk Check, a podcast from T.C. Jacoby & Company, where we share market insights and analysis with dairy farmers in mind. Ted Jacoby III: Welcome everyone to the March 28th, 2025, edition of The Milk Check, a T.C. Jacoby & Company podcast. It is my pleasure to welcome a couple of special guests to the podcast this week, first, Sarina Sharp of Ag Business Solutions and the Daily Dairy report. Welcome to the podcast, Sarina. Most of you know that Sarina is also the writer of the T.C. Jacoby Weekly Market Report, which we publish every Friday. Sarina, we're honored to have you join us today. More importantly, thank you for the partnership. I can't tell you how often I get compliments on the weekly report that you write for us, so thank you very much. Sarina Sharp: Thanks for having me. Thrilled to hear it. Ted Jacoby III: In addition, we have a few of our usual suspects: my brother Gus, head of our fluid group; Josh White, head of our dairy ingredients team, and I am excited to announce that Mike Brown, formerly of IDFA and Kroger fame, is joining the Jacoby team as our new vice president of Dairy Market Intelligence. Mike, I am excited to have you on the team, and I look forward to having you on this podcast as a regular presence. Mike Brown: Well, thank you, Ted. I'm delighted to be here. It's good to be back in markets and away from government regulation. I'm very excited about the opportunity. And Sarina, I am really looking forward to working with you. I've been a fan for decades now. Appreciate that opportunity to work with you as well. Sarina Sharp: Time flies. Ted Jacoby III: It sure does. So my first question is this. We've been talking for probably a couple of years now about the heifer replacements and the issue that's been evolving because many dairy farmers are breeding to beef simply because it's really hard to pass up $700 for a black cow rather than spending $3,000 to raise that calf into a heifer. But we're getting to the point where right now, for example, our traders that sell into the retail space, they're telling us demand's not that great. Those who are selling into the food service space are saying demand's not that great. Even our traders who export are telling us that Trump's rhetoric about tariffs is having an effect and making it difficult for us to export. In other words, demand is not that great on the horizon. Milk prices have come down. Class III price is probably going to be in the low 17s, maybe even into the high 16s in April. Are we getting to the point that we're starting to reach that line where dairy fa...

Cargill Kitchen Solutions is recalling nearly 215,000 pounds of its liquid egg products that were sold in Texas and other places because the food could possibly contain a cleaning solution made with sodium hypochlorite. The U.S. Department of Agriculture's Food Safety and Inspection Service said the recalled liquid egg items were produced on March 12 and 13, and have the establishment number “G1804” printed on the carton. The recall on the liquid egg products is considered Class III, which means FSIS scientists concluded that use of the item should not cause adverse health consequences – or the risk is negligible. However, consumers and foodservice locations are urged to not consume or serve these products; In other news, North Texas food providers are scrambling to find a way to fill a $9.2 million funding gap following cuts in March to two U.S. Department of Agriculture programs that bought food from local farmers; Dallas HERO threatened Monday to file a lawsuit if the city did not adhere to a November voter mandate to hire 900 more police officers and meet with the nonprofit to review the budget. It's the second time the nonprofit has said it would sue the city since voters approved two controversial changes to the city charter; and Texas House budget writers on Monday endorsed a $337.4 billion state spending plan for the next two years, sending it to the floor for a vote expected next week. Passing a balanced spending plan for the 2026-27 cycle, which starts in September Learn more about your ad choices. Visit podcastchoices.com/adchoices

Ever.Ag Principal Mike North says one of the reasons the Class III milk price is hindered is due to unknowns regarding retaliatory tariffs, notably with Canada and Mexico. In addition, milk production is rising. North emphasizes the need for producers to sign up for the Dairy Margin Coverage program. The deadline is March 31.See omnystudio.com/listener for privacy information.

A new organization is working to ensure rural Wisconsin thrives. The Rural Policy Institute is a coalition of agricultural and rural organizations. Executive Director Bob Welch says it's not an advocacy group, but a research organization. It starts with defining rural. A warm-up is coming your way along with showers. Stu Muck relies on weather observers through the National Weather Service. You could be one, too. Visit WisconsinWeatherWatchers.org. Wisconsin Farm Bureau's Jason Mugnaini says Ag Day at the Capitol was a success, welcoming 400 farmers and advocates. The celebration also got the public's attention with equipment, calves, and cheese on the Square. WFBF met with urban lawmakers in addition to rural policymakers. Conversations included ARIP funding and expanding Wisconsin product market opportunities. Brian Reisinger was a guest speaker at Ag Day with his book, Land Rich, Cash Poor. The book, which explores the history of disappearing farms, has resonated with policy and mental health groups across the state. "Naturally Wisconsin" is boosting the market for Wisconsin's all-natural products, explains Executive Director Jamie Valenti-Jordan. Ever.Ag Principal Mike North says one of the reasons the Class III milk price is hindered is due to unknowns regarding retaliatory tariffs, notably with Canada and Mexico. The deadline is April 2. See omnystudio.com/listener for privacy information.

In this episode, Hatem Rabeh will explain to us what are Clinical Data and also if there is a chance for you to avoid Clinical Investigations. There are also some confusion between Clinical Evaluation and Clinical Investigation. Let's clarify all this and give you the right strategies for your Medical Devices. So stay tuned.  Who is Hatem Rabeh?  Hatem Rabeh is a Medical Doctor with an MSc in Medical Engineering, specializing in clinical evaluation for medical devices.   With over 8 years of experience, he supports manufacturers in MDR compliance by preparing Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) for Class I to Class III devices, including software, implants, and robotic systems.  His expertise covers literature reviews, clinical strategy, and regulatory compliance.   Hatem also shares his knowledge through online training, consulting, and LinkedIn content.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Hatem Rabeh LinkedIn: https://www.linkedin.com/in/hatem-rabeh/  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

This podcast is the audio version of the Gear Garage Live Show, where we answer submitted questions and talk all things whitewater. Topics and links that Zach talked about this episode Ecuador Rowing School Answer Questions Some of the Questions that Zach covered in the Q&A section of this episode Topic: PFD Review Request Hey Zach, I love your channel! I have a quick question. Could you do a review on the Kokatat Maximus Centurion PFD? My apologies if you already have one in your library. Topic: Chetco How far does the Chetco go up from its mouth at the ocean before one hits a Class III? Topic: Sleeping Pad Hey Zach, love the show. I operate a small outfitting business and always appreciate your information and analysis. I'm repairing and replacing gear for the coming season and wondering what your favorite client sleeping pad is? Our trips all involve some bush flying so big pads like paco's are out of the question. I've been trying to find something a little more plush than the old standard therm-a-rest (Basecamp model) but have been plagued with leaky materials and valves. Love to know what you use. Topic: Maravia Glue Up Several years ago I bought a used 2009 Maraiva glue up boat. One of my seams has developed a leak and I am having trouble finding the right information on the proper repair of such a unique boat. If you have any info about this I would appreciate it. I love your YouTube Channel and what you guys do for the whitewater community. Topic: John Day SUP I stumbled upon your content about SUP adventure on the John Day. I am motivated to do something very similar and found your advice and tips helpful. I am reaching out to you regarding my plans and if you have insight as to the stretch of river I plan to paddle. John Day, 50 miles from Service Creek to Clarno (before the rapids I think). If you know what type of waters these are in June I would be grateful and very appreciative for any input you have. I feel pretty confident in my ability to handle class 2, but not sure about class 3.

Charitee Seebecker sits down with Chuck Connor, president and CEO of the National Council of Farmer Cooperatives. As we kick off 2025, he says farmers across the country are facing a mix of big challenges and new opportunities. For example, this year, $4 trillion in tax deductions will expire unless Congress intervenes. These include provisions crucial to farmers, such as estate tax relief.Ag meteorologist Stu Muck says a thaw is coming this weekend when temps get above freezing. Snow continues to fall in Southeast Wisconsin.Thousands of dollars, hardworking people, and good weather - that's what it takes to make a successful county fair concert. Talent buyer Variety Attractions works with county fairs in the Upper Midwest to line up musical artists. They tell Mid-West Farm Report what the hot music bands are for 2025.Katie Burgess, Ever.Ag, says volatility is back in the Class III market with large swings up or down day by day. Post-inauguration, she says the talk of a possible trade war with Mexico would not bode well for dairy. Regardless of the risk coming your way, she advises looking into the Dairy Margin Coverage program. Enrollment opens Jan. 29.See omnystudio.com/listener for privacy information.

Send us a textLast month, the FAA announced changes in screening for color vision deficiency.  On this episode we discuss what pilots will be directly affected and address some of the common questions being asked right now by our patients and aviation medical examiners across the country. What tests will be allowed? What happens if my AME doesn't have one of the new approved computer-based color vision screening tests? What happens if I have a color vision waiver now with a Class III medical and want to move up to a Class I or Class II certificate?

Today's dairy market is global. In our latest episode of The Milk Check, we dive into the New Zealand and Oceania markets to understand how they may impact the U.S. dairy market. Join Jacoby and our two special guests Jo Bills, ag market analyst and director of global Insights at Ever.Ag, and Steve Spencer, managing Director at Ever.Ag as we dive into dairy. Tight global supplies of skim milk powder and strong demand will likely keep prices high through 2025 New cheese plants in the U.S. market increase Class III supply and may drive cheese prices down and limit powder output, tightening global powder supply New Zealand enjoys tariff-free access to the Chinese market, but China's economic woes have reduced dairy demand Lower Chinese demand pushed New Zealand to focus on skim milk powder, butterfat, and cheese And lots more information on the global dairy market and our predictions 2025. We have a positive outlook for dairy in 2025, but cheese may be our wild card. Get the market scoop from the Jacoby team, including Ted Jacoby, III, CEO & President, Cheese, Butter & Dry Ingredients; Josh White, Vice President, Dairy Ingredients; and Diego Carvallo, Director of Dry Dairy Ingredient Trading. Intro (with music): Welcome to The Milk Check, a T.C. Jacoby & Company podcast where we share market insights and analysis with dairy farmers in mind. Ted Jacoby, III (T3) Hello, everybody, and welcome to The Milk Check. This month, we are excited to welcome special guests Joanne Bills and Steve Spencer from Freshagenda to share their thoughts on milk production and dairy demand in Asia, Oceania, and internationally for 2025. Joining us from the Jacoby team are Josh White and Diego Carvallo from our dairy ingredients team. Welcome, everybody, and thank you for joining us today. Steve Spencer: Thank you, Ted. It's great to be here. We enjoy these. We've done a few of these, so it's always good fun. T3: We're about to enter year two of China's tariff changes regarding New Zealand dairy products and how they are imported into China. For our audience, many of whom are dairy farmers here in the U.S., why don't you give us a quick overview of those changes? Then, we can discuss what that has meant for dairy markets in that region and how it affects dairy prices. Steve: In basic terms, New Zealand has tariff-free access to the Chinese market. That was preset for an extended period. They were on a slow rundown of tariffs over a long haul. A few years before that was due, they had a review, and it seemed to be that that was just a little period to push it out a bit longer, and that's in the rearview now. So, we're in a very tariff-free environment for New Zealand exports, which you'd think has freed them up to go wild. The only trouble is China's not a market that is allowing many people to go wild right now because that's come at the same time as China hitting a phase of the second wave after Covid; the second wave lockdowns were much harsher, much longer, much more damaging to the economy and so that's crippled demand for dairy in many parts of the market because spending, consumer spending has been depressed and many things are contributing to that right now and that's still a happening thing. So, that has freed New Zealand up to grow its share of the market in skim milk, powder, cheese, and butterfat and they've certainly done that at a time when the import volumes are a lot lower. So, we've got to sit back and look at the overall trends in China. We think they're just off the bottom regarding those import trends, but New Zealand has certainly picked up share, and their exports to China are falling. You could take the story of product by product because the products that China isn't producing or doesn't produce, skim milk, powder, butterfat, cheese, a small production of those, really the trade is probably following the pattern of demand we're seeing in that market.

Today's dairy market is global. In our latest episode of The Milk Check, we dive into the New Zealand and Oceania markets to understand how they may impact the U.S. dairy market. Join Jacoby and our two special guests Jo Bills, ag market analyst and director of global Insights at Ever.Ag, and Steve Spencer, managing Director at Ever.Ag as we dive into dairy. Tight global supplies of skim milk powder and strong demand will likely keep prices high through 2025 New cheese plants in the U.S. market increase Class III supply and may drive cheese prices down and limit powder output, tightening global powder supply New Zealand enjoys tariff-free access to the Chinese market, but China's economic woes have reduced dairy demand Lower Chinese demand pushed New Zealand to focus on skim milk powder, butterfat, and cheese And lots more information on the global dairy market and our predictions 2025. We have a positive outlook for dairy in 2025, but cheese may be our wild card. Get the market scoop from the Jacoby team, including Ted Jacoby, III, CEO & President, Cheese, Butter & Dry Ingredients; Josh White, Vice President, Dairy Ingredients; and Diego Carvallo, Director of Dry Dairy Ingredient Trading. Intro (with music): Welcome to The Milk Check, a T.C. Jacoby & Company podcast where we share market insights and analysis with dairy farmers in mind. Ted Jacoby, III (T3) Hello, everybody, and welcome to The Milk Check. This month, we are excited to welcome special guests Joanne Bills and Steve Spencer from Freshagenda to share their thoughts on milk production and dairy demand in Asia, Oceania, and internationally for 2025. Joining us from the Jacoby team are Josh White and Diego Carvallo from our dairy ingredients team. Welcome, everybody, and thank you for joining us today. Steve Spencer: Thank you, Ted. It's great to be here. We enjoy these. We've done a few of these, so it's always good fun. T3: We're about to enter year two of China's tariff changes regarding New Zealand dairy products and how they are imported into China. For our audience, many of whom are dairy farmers here in the U.S., why don't you give us a quick overview of those changes? Then, we can discuss what that has meant for dairy markets in that region and how it affects dairy prices. Steve: In basic terms, New Zealand has tariff-free access to the Chinese market. That was preset for an extended period. They were on a slow rundown of tariffs over a long haul. A few years before that was due, they had a review, and it seemed to be that that was just a little period to push it out a bit longer, and that's in the rearview now. So, we're in a very tariff-free environment for New Zealand exports, which you'd think has freed them up to go wild. The only trouble is China's not a market that is allowing many people to go wild right now because that's come at the same time as China hitting a phase of the second wave after Covid; the second wave lockdowns were much harsher, much longer, much more damaging to the economy and so that's crippled demand for dairy in many parts of the market because spending, consumer spending has been depressed and many things are contributing to that right now and that's still a happening thing. So, that has freed New Zealand up to grow its share of the market in skim milk, powder, cheese, and butterfat and they've certainly done that at a time when the import volumes are a lot lower. So, we've got to sit back and look at the overall trends in China. We think they're just off the bottom regarding those import trends, but New Zealand has certainly picked up share, and their exports to China are falling. You could take the story of product by product because the products that China isn't producing or doesn't produce, skim milk, powder, butterfat, cheese, a small production of those, really the trade is probably following the pattern of demand we're seeing in that market.

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with regulatory expert Dr. Mike Drues to demystify the pre-market approval (PMA) process for medical devices. They delve into the key differences between PMAs, 510(k)s, and de novos, bust common myths, and explore strategic advantages for companies willing to pursue the rigorous PMA pathway. Mike explains the nuances of the “six-year rule,” alternatives like the humanitarian device exemption (HDE), and the evolving role of clinical data. With insights on using PMAs as a competitive strategy and overcoming internal resistance to high-risk device development, this discussion is essential for MedTech innovators looking to turn regulatory challenges into opportunities.Key Timestamps:00:00 – Intro and Greenlight Guru's Quality Management System software sponsor message03:15 – Introduction to Dr. Mike Drues and his background in PMAs05:45 – Overview of PMAs and when they should be used11:30 – Are PMAs the only pathway for Class 3 devices?16:20 – Types of PMAs: Traditional, Modular, and Streamlined22:40 – Advantages of PMAs compared to 510(k)s and de novos27:50 – The strategic use of predicates in the PMA process33:00 – Clinical data requirements and misconceptions for PMAs41:10 – Post-market requirements and differences for PMA devices47:25 – Innovation and the future of PMAs: Six-year rule and potential EU approvals54:30 – Final thoughts on overcoming industry resistance to PMAsStandout Quotes:"Don't be afraid of the big bad PMA—often, the regulatory burden is justified for complex devices tackling high-risk conditions." – Dr. Mike Drues"Regulatory professionals know the rules; the best ones know the exceptions. When it comes to PMAs, there are more options than many realize." – Dr. Mike Drues3 Key Takeaways:PMA Isn't the Only Path for Class 3 Devices: Companies can consider alternatives like the Humanitarian Device Exemption (HDE) and Product Development Protocol (PDP) to reduce the regulatory burden.Strategic Use of PMAs Can Provide a Competitive Edge: By choosing the PMA route, companies can create barriers for competitors, potentially driving smaller rivals out of the market.Clinical Data Isn't Always Mandatory for PMAs: While most PMAs involve clinical trials, there is flexibility in requirements, offering an opportunity to minimize the scope and cost of clinical studies.References:Previous Greenlight Guru Webinars by Dr. Mike DruesGreenlight Guru's QMS SoftwareEtienne Nichols' LinkedInMedTech 101:PMA Pathway Explained – Pre-market approval (PMA) is the FDA's strictest regulatory pathway, typically reserved for Class 3 medical devices with higher risks. Unlike the 510(k) pathway, PMA requires evidence of safety and efficacy, often through clinical trials, but the scope can vary. There are traditional, modular, and streamlined PMA types, each with unique requirements.Audience Engagement:Poll Question: "Have you considered using a PMA as a strategic advantage for your MedTech device? What challenges do you...

In this episode of the Uplevel Dairy Podcast, host Peggy Coffeen dives into the current landscape of dairy markets with Curtis Bosma from HighGround Dairy. The episode starts by giving listeners an overview of recent trends in dairy futures, including notable gains in Class III and Class IV prices and the implications for dairy producers. Curtis shares insights on the influence of managed money in the commodity markets and what this indicates about future market movements.Throughout the episode, Curtis discusses the critical impact of diseases such as the Blue Tongue virus in Europe and the H5N1 avian influenza in California. He highlights how these events affect global and local dairy production and what dairy farmers need to watch for regarding their milk supply and pricing. Curtis also offers advice on how dairy producers can navigate these tumultuous times by leveraging risk management strategies.The episode wraps up with an in-depth conversation about valuing corn silage, especially during the current harvest season. Curtis breaks down the various factors that should be considered, from managing shrinkage to understanding the financial implications of either growing or purchasing corn silage. This timely discussion is aimed at helping dairy farmers make informed decisions about their feed strategy to ensure financial stability and operational efficiency. Grab your September Market Report Here:  https://marketing.highgrounddairy.com/producer-market-update-september-2024. Information shared in this podcast is for educational purposes and is not a solicitation to buy or sell commodities.  Opinions expressed are current opinions as of September 18, 2024 at 10 a.m. CST and only represent the views of the speaker and not those of HighGround Trading, unless otherwise expressly noted.

In this episode, Nick and Don catch-up with Bluberi's Chief Product Officer, Mike Brennan, and Chief Commercial Officer, Casey Whalen. Learn how an insurgent supplier with roots in Quebec is parlaying a string of surprise hits into some of the most exciting product offerings for the Class III slot space. Hear about their design philosophies, banking strategies, release plans, cultural imperatives, and (music to our ears) obsession with fair share performance. Also in this episode, G2E 2024.  © 2015 -2024 RM Holdings B.V. and ReelMetrics B.V. All rights reserved.For transcripts of ReelCast episodes, please see https://www.reelmetrics.com/reelcast.For legal statements apropos of this and other ReelMetrics content / "Materials", please see https://www.reelmetrics.com/legal

The Class III milk and cheese prices have seen fireworks in the past few weeks. Ryan Yonkman, the vice president of producer services for Ever.Ag, says it's due to bullish buying events and reports stacking up on each other.See omnystudio.com/listener for privacy information.

Ryan Yonkman, the vice president of producer services for Ever.Ag, says it's due to bullish buying events and reports stacking up on each other.

The Class III milk and cheese prices have seen fireworks in the past few weeks. Ryan Yonkman, the vice president of producer services for Ever.Ag, says it's due to bullish buying events and reports stacking up on each other.

We kick off our Ian Marter retrospective with a look at his time at Oxford University. Thanks to back issues of St. Edmund Hall Magazine, we uncover new information that places Marter at Oxford three years earlier than is widely and incorrectly reported in other published sources. From our research, we found that Marter was at St. Edmund Hall, aka Teddy Hall, from 1963-1966 and was heavily involved with drama in the college's John Oldham Society and the Oxford's drama cuppers.Before Oxford, Marter went to school at the Beckenham and Penge Grammar School in Greater London and went to Oxford on a scholarship to study English language and literature. Among other highlights, Marter directed a well received production of John Osbourne's Luther in 1964 during the Trinity Term of his freshman year at the Oxford Playhouse. He also acted in productions of Fire in Heaven, The Sport of My Mad Mother, and Anton Checkov's The Cherry Orchard. In his final year at St. Edmund Hall, Marter co-starred in Samuel Beckett's play, Waiting for Gadot and was in Richard Burton's production of Doctor Faustus, by Christopher Marlowe which was also released as a film in 1967, giving Marter his first screen credit. Marter was awarded a Class III degree from St. Edmund Hall, which may help explain why he never corrected the record about his time at Oxford.After leaving Oxford in 1966, he landed an assistant stage manager job at the Bristol Old Vic and by the following year, he was acting once again. We briefly talk about his small role in the Vincent Price horror film, The Abominable Dr. Phibes, and his reoccurring role in ITV's Crown Court where he played a police constable and then barrister, Quentin Ingrams, QC. Finally, we discuss being cast as Lt. John Andrews in "Carnival of Monsters" and how Doctor Who may have been different if he landed the role of Capt. Mike Yates a few years earlier. The opening and closing music is "Sinfonietta: IV. Allegrteto," composed by Leoš Janáček and performed by the Pro Arte Orchestra, which was the opening theme for ITV's Crown Court. We recorded this episode on 12-13 August 2024.

In this episode, Nick and Don speak with Derik Mooberry, CEO of Zitro USA. Learn about Zitro's rise from niche electronic bingo provider to a global supply-side powerhouse, its plans for the North American market, and the company's increasingly compelling Class III slot portfolio. Also in this episode, leveraging superstar inventory to dial-back free play. © 2015 -2024 RM Holdings B.V. and ReelMetrics B.V. All rights reserved.For transcripts of ReelCast episodes, please see https://www.reelmetrics.com/reelcast.For legal statements apropos of this and other ReelMetrics content / "Materials", please see https://www.reelmetrics.com/legal

This quarter two seismic shifts occurred in the United States and Germany with a common denominator: the DEA advanced the rescheduling of cannabis from a narcotic to a Class III drug in the USA, and Germany completed the rescheduling with passage of the Cannabis Reform Law April 1. However, the implications are different for the two largest cannabis markets. Join us for a fireside chat with Arthur de Cordova, a former Country Manager for AstraZeneca in Europe, and CEO of Ziel.

Andy discusses his background growing up on a farm and how it shaped his work ethic. He talks about his experience founding Engineering Consultants and working with medical device startups. Key topics include challenges in commercializing devices, balancing an inventor's vision with engineering feasibility, and advice for engineers entering the field.Main Topics: Medical device regulationsChallenges in commercializationBalancing an inventor's visionStem cell and gene therapy advances in ophthalmologyAdvice for young engineers About the guest: Andy Schieber is a seasoned medical device engineer and entrepreneur with extensive experience in research and development. He is the Founder and President of Ingenarious Consultants, a firm that specializes in early-stage medical device development, offering services from concept to clinical trials. Andy has a remarkable track record in designing and developing Class III implantable medical devices, and he holds over 40 patents including the Hydrus Microstent, which is a significant innovation in ophthalmology.He also serves as the Head of Engineering at Rivermark Medical, where he contributes to the development of novel medical technologies. Andy's educational background includes a Master's degree in Mechanical Engineering from the University of Minnesota and a Bachelor's in Engineering from the University of Wisconsin-Stout​.Links:Andy Schieber - LinkedInIngenarious Consultants WebsiteAbout Being An Engineer The Being An Engineer podcast is a repository for industry knowledge and a tool through which engineers learn about and connect with relevant companies, technologies, people resources, and opportunities. We feature successful mechanical engineers and interview engineers who are passionate about their work and who made a great impact on the engineering community. The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment such as cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us on the web at www.teampipeline.us

The Class III milk market has experienced significant volatility recently, with prices fluctuating and market participants seeking clear direction.  NAFB News ServiceSee omnystudio.com/listener for privacy information.

Summer is here, and the high-water season for recreational paddlers has reached Colorado's iconic rivers. While Colorado manages 43 state parks, the Arkansas Headwaters Recreation Area is among the most unique in that it spans across a 152-mile corridor that follows the Arkansas River from the high mountains near Leadville to Lake Pueblo.AHRA isn't only a whitewater destination, though. It also boasts eight developed campgrounds and 19 dispersed camping areas while also offering gold-medal fishing, incredible wildlife viewing and hiking and climbing opportunities.Still, it's the whitewater that many think of first when it comes to AHRA. It's one of the nation's most popular rafting and kayaking destinations and is the most commercially rafted river in the United States.Along with that many boaters and stretches of Class III to Class V rapids comes challenges for CPW staff. AHRA rangers have already responded to multiple rescue calls this year, and there has already been one kayaking fatality in early June.In this episode, hear from AHRA Manager Tom Waters and River Ranger Supervisor Jeffrey Hammond on what it takes to manage AHRA, the diversity of the rescue and recovery situations they find themselves in and the ever-present danger that comes with whitewater recreation

Tisotumab vedotin garners a regular FDA approval for metastatic cervical cancer with OS benefit data. A lingering question that demands a focused RCT: What is the optimal dose of methotrexate in primary CNS lymphoma? I'm glad I'm not the only one with this question: https://doi.org/10.1177/10781552231176754 What, some BRAF mutations in colorectal cancer might respond to EGFR-mab therapy? https://doi.org/10.1200/OP.21.00160

Sponsor: Medboard: https://www.medboard.com/ EU MDR and IVDR national languages update - France accepts English MDR: https://health.ec.europa.eu/document/download/aa9760e3-c864-4173-8b16-d790dac66d74_en?filename=md_sector_lang-req-table-mdr.pdf IVDR: https://health.ec.europa.eu/document/download/1e312d8f-8b34-45da-a5fa-1918ba618aca_en?filename=md_sector_lang-req-table-ivdr.pdf   Which devices for Expert Panel - Active Implantable Device on Top: https://health.ec.europa.eu/document/download/4c43abea-b989-434b-9ac1-94134bf1a538_en?filename=md_annual-overview-cecp-2022-2023_en.pdf 94.4% for Class III implantable and 5.6% for Class Iib Administer or remove medicinal products On Class III implantable - Top is with Active Implantable Devices Exempt devices are mainly within 3 categories (Main reason: Modification of a device already marketed): Vascular and cardiac prostheses Orthopaedic prostheses, osteosynthesis devices, devices for tendon and ligaments synthesis Implantable prosthetic and osteosynthesis devices     Annex XVI: Is Brain Stimulation device risk? -  SCHEER should evaluate by End 2025: https://health.ec.europa.eu/document/download/e6de1e88-2821-48f6-98f9-a56ea61cbfad_en?filename=scheer_q_031.pdf SCHEER = Scientific Committee on Health, Environmental and Emerging Risks   SCHEER on Phtalate - Update of the guidelines: https://health.ec.europa.eu/consultations/scheer-public-consultation-preliminary-update-scheer-guidelines-benefit-risk-assessment-presence_en Consultation until April 28th, 2024   MDCG subgroup Agenda - What is coming?: https://health.ec.europa.eu/document/download/f588a5c8-57af-48aa-808f-1d9c02f4925a_en?filename=mdcg_ongoing-guidance_0.pdf MDCG 2024-3 on CIP - Clinical Investigation: https://health.ec.europa.eu/document/download/690de85a-ac17-45ea-bb32-7839540c25c4_en?filename=mdcg_2024-3_en.pdf New Notified Body RISE Sweden - Welcome to the team 3033: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=d37c034bc695d2e143b5145b4cb7cd73caf8983c&group=NOTIFICATION&download=true 44 MDR NB 12 IVDR NB   UK MHRA: Electrical Devices in Clinical Trials - Advice on application with separate document: https://assets.publishing.service.gov.uk/media/65fb0d66aa9b76001dfbdc28/MHRA_Electrical_Guidance_for_Clinical_Investigations_Modified_12_Feb.pdf Ireland HPRA Newsletter- IVD, Eudamed, Custom-made, Clinical trials: https://www.hpra.ie/docs/default-source/publications-forms/newsletters/hpra-medical-devices-newsletter-issue-57-february-2024.pdf Turkey Reminder on MDR transition period - May 26th, 2024: https://titck.gov.tr/storage/Archive/2024/announcement/duyurumetni_67231ed0-2553-4708-8231-7951c767e066.pdf Turkey strongly inform the different parties regarding MDR transition   Events RAPS Euro Convergence - May 6-8 in Berlin-Germany: https://www.raps.org/europe-2024/home Medtech Conf Map: https://medtechconf.com/event/connect-with-european-andinternational-regulatoryaffairs-peers-in-berlin-2/ Services Packaging for Medical and Pharmaceutical - Design, Manufacturing and delivery: https://easymedicaldevice.com/packaging-for-medical-devices/ ROW USA Ban devices - Electrical Stimulation Devices for Self-injurious or Aggressive Behavior: https://www.fda.gov/medical-devices/medical-device-safety/medical-device-bans CNN article: https://edition.cnn.com/2024/03/25/health/fda-ban-electrical-stimulation-devices/index.html Comments open until May 28, 2024: https://www.fda.gov/medical-devices/medical-devices-news-and-events/fda-proposes-new-ban-electrical-stimulation-devices-self-injurious-or-aggressive-behavior Bans Prosthetic Hair Fibers since 1983 Powdered Surgeon's Gloves since 2017 Electrical Stimulation Devices for Self-injurious or Aggressive Behavior since March 2024     Animal Studie for Dental Bone Grafting devices - Choose the right animal Model: https://www.fda.gov/media/177340/download Minimum of 3 animals Animal Model: Canine and Porcine model instead of rodents   FDA: Deviations on Neuralink lab - Animal Study good practices: https://www.reuters.com/business/healthcare-pharmaceuticals/fda-finds-problems-animal-lab-run-by-musks-brain-implant-company-2024-02-29/ Calibration of equipment's are not done Quality officials not signing documents   Australia Vigilance Reporting in Australia - For Recall and non-Recall: https://www.tga.gov.au/sites/default/files/2024-03/uniform-recall-procedure-therapeutic-goods-urptg.pdf Recall action Template: https://www.tga.gov.au/resources/resource/forms/recall-action-templates   Saudi Arabia Guidance on Surgical Sutures - This contains some cheat code: https://www.sfda.gov.sa/sites/default/files/2024-03/%28MDS-G021%29En.pdf Endpoints that should be addressed Laboratories should be ISO/IEC 17025 Shelf life should follow ASTM F1980   Brazil MOU between Brazil and Paraguay - Memorandum of Understanding: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/anvisa-e-agencia-reguladora-do-paraguai-assinam-primeiro-memorando-de-entendimento Bilateral cooperation on health surveillance Strenghtening regulatory capacity   GMP validity from two to four years - If certified through MDSAP: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/anvisa-amplia-para-quatro-anos-prazo-de-validade-do-certificado-de-boas-praticas-de-fabricacao Prioritize registration of Dengue Diagnosis Devices - Submit Now: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/anvisa-prioriza-registro-de-dispositivos-para-diagnostico-da-dengue Combat dengue epidemic as a matter of urgency   India CDSCO: PSUR through online portal - From April 1st, 2024: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTEwMTI= Online portal: https://www.cdscomdonline.gov.in/NewMedDev/Homepage   Malaysia Malaysia Faster approval - Establishment license application: https://www.mda.gov.my/index.php/announcement/1377-faster-approval-for-establishment-license-application-complete-applications-processed-within-14-21-working-days 14 to 21 Working days from date of application List of documents within the link   China China Guidelines on registration - Specific products: https://www.cmde.org.cn/xwdt/zxyw/20240318133300123.html Corneal Topograph Laparoscopic surgery system Optical Radiation Safety device Monkeypox virus nucleid acid detections agent: https://www.cmde.org.cn/xwdt/zxyw/20240318111545184.html   Podcast Podcast Nostalgia Episode 275 - FDA aligns QMSR with ISO 13485 (Naveen Agarwal): https://podcast.easymedicaldevice.com/275-2/Episode 276 - How to do Postmarketing Surveillance to right way? (Steve Curran): https://podcast.easymedicaldevice.com/276-2/ Episode 277 - How to benefit from Survey to build Clinical Evidence? (Cesare Magri): https://podcast.easymedicaldevice.com/277-2/   Easy Medical Device info@easymedicaldevice.com Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

In this episode, Tim Boire and Geoff Lucks at VenoStent and Duane Mancini discuss their background in the Medtech space, how they founded VenoStent, their clinical trial, fundraising strategy, and its correlation to achieving milestones and so much more.

In this episode, Dave Tinker discusses the importance of accessibility in fundraising. He shares his personal connection to the disability community and explains why making the world more inclusive is a passion of his. Dave provides practical tips for interacting with constituents with disabilities and highlights the curb cut effect in fundraising. He also discusses the importance of incorporating accessibility features on websites and social media platforms. Dave emphasizes the ethical and strategic importance of accessibility and encourages organizations to stand out by prioritizing accessibility in their communications. He concludes by providing his contact information for further discussion.TakeawaysIncorporating accessibility in fundraising is important to ensure inclusivity for all potential donors.Interacting with constituents with disabilities should be done in a way that is accessible and accommodating.Websites and donation pages should include accessibility features such as alt tags and high contrast colors.Direct mail should also consider accessibility through large fonts and clear layouts.Tracking data on donors with accessibility needs can help organizations better understand and serve this audience.Building websites and communications with accessibility in mind is both ethical and strategic.There are various tools and resources available to help organizations improve website accessibility.Guest BioDave is Vice President of Advancement at Achieva and a consultant with GoalBusters Consulting. In these roles he raises funds and helps nonprofits with their communications. He was also an adjunct professor of informatics at Muskingum University for over a decade. A certified Association of Fundraising Professionals (AFP) Master Trainer, he received the Outstanding Fund Raising Executive Award from the AFP Western PA chapter in 2013. In October 2016 he was honored by AFP International as one of six in the inaugural class of Distinguished Fellows. Dave has published numerous articles in professional journals and has written fundraising curriculum for The Fund Raising School® at the Lilly Family School of Philanthropy at Indiana University and the Alliance for Strong Families and Communities.Dave is a past president of the AFP Western PA chapter and has served in many volunteer roles for AFP International and his own chapter. In addition to AFP, Dave has served as a member of the Ethics Committee for the Grant Professionals Association where is also an approved trainer. Dave received a Master of Public Affairs with a concentration in Nonprofit Management from the Lilly Family School of Philanthropy at Indiana University. He received a Bachelor of Arts in Chemistry and English and a Master of Information Strategy, Systems and Technology from Muskingum University. He is also a graduate of Leadership Works - Indianapolis, Class III and the National Leadership Consortium on Developmental Disabilities at the University of Delaware, Class 44.Chapters02:03 Dave's Passion for Accessibility in Fundraising03:26 Incorporating Accessibility in Daily Interactions04:53 The Curb Cut Effect in Fundraising05:56 Interacting with Constituents with Disabilities06:04 Technological Considerations for Website Donation Pages07:36 Using Alt Tags on Social Media Platforms08:32 The Future of Accessibility in Fundraising10:45 Tips for Creating Accessible Websites and Donation Pages12:56 Considerations for Direct Mail Accessibility17:37 Tracking Data on Donors with Accessibility...

The following question refers to Section 4.9 of the 2021 ESC CV Prevention Guidelines. The question is asked by Dr. Christian Faaborg-Andersen, answered first by UCSD fellow Dr. Patrick Azcarate, and then by expert faculty Dr. Melissa Tracy. Dr. Tracy is a preventive cardiologist, former Director of the Echocardiography Lab, Director of Cardiac Rehabilitation, and solid organ transplant cardiologist at Rush University. The CardioNerds Decipher The Guidelines Series for the 2021 ESC CV Prevention Guidelines represents a collaboration with the ACC Prevention of CVD Section, the National Lipid Association, and Preventive Cardiovascular Nurses Association. Enjoy this Circulation 2022 Paths to Discovery article to learn about the CardioNerds story, mission, and values. Question #35 In patients with a low risk of cardiovascular disease, which of the following is true?AAspirin does not affect the risk of ischemic strokeBAspirin increases the risk of fatal bleeding.CAspirin reduces the risk of non-fatal MI.DAspirin reduces cardiovascular mortality Answer #35 ExplanationIn 2019, an updated meta-analysis of aspirin for primary prevention of cardiovascular events found that patients with a low risk of CVD taking aspirin did not have a reduction in all-cause or cardiovascular mortality. There was a lower risk of non-fatal MI (RR 0.82) and ischemic stroke (RR 0.87). However, aspirin was also associated with a  higher risk of major bleeding (RR 1.50), intracranial bleeding (RR 1.32), and major GI bleeding (RR 1.52). There was no difference in the risk of fatal bleeding (RR 1.09).Accordingly, the ESC does not recommend antiplatelet therapy in individuals with low/moderate CV risk due to the increased risk of major bleeding (Class III, LOE A).Although aspirin should not be given routinely to patients without established ASCVD, we cannot exclude that in some patients at high or very high CVD risk, the benefits may outweigh the risks.Main TakeawayIn patients with low/moderate risk of CVD, aspirin for primary prevention is not recommended due to the higher risk of bleeding. For those at higher risk of CVD, low-dose aspirin may be considered for prevention in the absence of contraindications.Guideline Loc.Section 4.9.1, Page 3291 CardioNerds Decipher the Guidelines - 2021 ESC Prevention SeriesCardioNerds Episode PageCardioNerds AcademyCardionerds Healy Honor RollCardioNerds Journal ClubSubscribe to The Heartbeat Newsletter!Check out CardioNerds SWAG!Become a CardioNerds Patron!