Podcasts about Kirsh

This episode may be the most spiritually rich conversation to date on the Upwardly Dependent podcast. Dr. Krish Kandiah, and Officer of the British Empire and long-time advocate for refugees and orphans, shares incredible stories and deep reflections from his love for God's word. As the last guest in this series on Orphans and Vulnerable Children, you will be sure to find a renewed passion for not only neighboring well, but also for resting in the love of a Creator who pursues you, as well. There aren't appropriate words to describe the impact this conversation could have on you, so just go ahead and give it a listen. ... Episode Highlights Intro to Dr. Krish and his work as an Officer of the British Empire (3:29) Wrestling with the responsibility of privilege (6:19) Dr. Krish's heart for adoption and supporting refugees (9:02) Understanding God's heart for people on the margins (16:37) A holistic theology informing our care for vulnerable children (22:42) The holiness of slowing down and inviting others in (29:47) Racializing and dehumanizing vulnerable families (31:55) A call to the Church to protect vulnerable children (42:18) ... For more information, details, and episode transcriptions, visit ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠upwardlydependent.com/shownotes⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠. ... Links ⁠⁠⁠Kindred Exchange⁠⁠⁠ - Become a monthly donor to support this show and our mission ⁠⁠⁠Emmaus House⁠⁠⁠ - Learn more about their work with orphaned youth in Haiti  Dr. Krish's Website - Learn more about Dr. Kirsh and the work he is doing to help to solve problems through partnerships across civil society, faith communities, government and philanthropy. The Sanctuary Foundation - Learn how they are providing compassionate service to vulnerable people through catalytic partnerships between government, churches, civil society groups, the media and individuals. ... Connect with Lauren ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Email⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ / ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Instagram⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ / ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Leave a Review⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Connect with Dr. Krish X / Linkedin

High-Tech Healing: Izzy Kirsh Unveils mode's Cannabis RevolutionIn this podcast episode, Bruce Eckfeldt interviews Izzy Kirsh, the founder and CEO of mode, a company focusing on innovative cannabis consumption devices. They discuss various aspects of the cannabis industry, including consumer trends, product innovation, and challenges in the market.Izzy begins by sharing his background, mentioning his experience in product design and technology startups. He explains how his interest in cannabis was sparked by personal experiences with chronic pain and the need for more precise dosing options.The conversation delves into Mode's journey, from ideation to product development. Izzy highlights the challenges they faced in securing funding due to the cannabis industry's unique regulatory landscape. Despite these hurdles, mode developed a sophisticated dosing platform integrated with a mobile app, aiming to provide users with personalized cannabis consumption experiences.They discuss the design choices behind Mode's product, emphasizing its user-friendly interface and premium aesthetics. Izzy explains the importance of catering to both medical patients and recreational users while maintaining a health and wellness-focused brand image.They also touch on the data collection aspect of mode's platform, which gathers anonymized user data to improve dosing recommendations and product efficacy. Izzy outlines their vision for expanding internationally and potentially diversifying into related industries such as nicotine cessation and psychedelics.Finally, Izzy reflects on the challenges of marketing cannabis-related products in a restrictive online environment and expresses optimism about the industry's future as regulatory barriers evolve.Overall, the conversation provides insights into mode's innovative approach to cannabis consumption and its potential to shape the future of the industry.https://www.linkedin.com/in/izzykirsh/ 

How did Nextracker become the leading solar tracker manufacturer in the world in 10 years, and what was the secret sauce of one of the most successful IPO's of 2023? We finally have Nextracker's Senior Vice President of Marketing, Kristan Kirsh, on the show sharing her journey of helping elevate Nextracker from 400 Megawatts to 90 Gigawatts in shipped solar trackers.With Kirsh running marketing since 2015, Nextracker has not only navigated its landmark public offering but has also cemented its status as an industry icon. This episode delves into the strategic layers of her successful marketing prowess that has served as exemplar within the solar sector, offering listeners a chance to explore:The creation of a customer-centric culture that goes beyond listening to actively incorporate feedback into both product development and marketing strategies.The use of storytelling to make complex technological solutions relatable and captivating in a way that's meaningful to the audience.The importance of diversity and inclusion in fostering a creative and robust marketing team, and how to encourage diversity and inclusion at a high level.Strategies for managing significant milestones, from tactically naming products to dealing with multiple stakeholders in the IPO process.Nextracker's philanthropy, supporting nonprofits like Green Empowerment with small-scale solar projects in Africa and Latin America.This interview with Kristan Kirsch demonstrates the power of strategic marketing, cultural and global diversity, and truly empowering others to elevate the industry. And we had the honor of bringing it to you live in-person from the comfort of Kristan's Bay Area living room! (so, definitely tune in on Youtube and watch!)If you want to connect with today's guest, you'll find links to his contact info in the show notes on the blog at https://mysuncast.com/suncast-episodes/.SunCast is presented by Sungrow, the world's most bankable inverter brand.SunCast is also supported by Trina.You can learn more about all the sponsors who help make this show free for you at www.mysuncast.com/sponsors.Remember, you can always find resources, learn more about today's guest and explore recommendations, book links, and more than 650 other founder stories and startup advice at www.mysuncast.com.Subscribe to Valence, our weekly Linkedin Newsletter, and learn the elements of compelling storytelling: https://www.linkedin.com/newsletters/valence-content-that-connects-7145928995363049472/You can connect with me, Nico Johnson, on:Twitter - https://www.twitter.com/nicomeoLinkedIn - https://www.linkedin.com/in/nickalus

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here's what you need to know for today, January 19, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Onward began a study of its neurostimulation technology for addressing post-spinal cord injury hemodynamic instability. Fast Five hosts Sean Whooley and Danielle Kirsh look at what this study aims to accomplish and discuss how Onward applies its technology in a variety of ways. The FDA approved expanded labeling for the Abbott Proclaim neurostimulation system, allowing those implanted with the device to receive full-body MRI scans. The hosts look into the importance of MRI compatibility and how the Proclaim system works. Orthofix partnered with MRIguidance, combining surgical navigation technology with innovative software. Find out what this partnership entails and how the companies feel about their latest development. Medtronic reported positive data for multiple spinal cord stimulation technologies. Hear about some of the key results from the medtech giant's studies presented at the North American Neuromodulation Society (NANS) annual meeting in Las Vegas. Abbott announced the first procedures completed with its Volt pulsed field ablation system. Whooley and Kirsh take a look at the latest entry into the crowded PFA space and examine what could potentially set Abbott's new technology apart.

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here's what you need to know for today, January 10, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Orthofix appointed a new CFO as Massimo Caliafiore took over as CEO. Fast Five hosts Danielle Kirsh and Sean Whooley discuss who takes on the financial leadership role and some of their career history.  Dexcom has submitted a new glucose sensor to the FDA and expects to launch it this summer. Whooley explains what the technology does and the launch plans Dexcom has. Megadyne Medical, part of J&J's Ethicon, has a new recall of patient return electrodes. The Fast Five hosts go over the reason behind the recall and what users of the device should do with the recalled technology. Insulet has a Class I recall for its Omnipod 5 Andrioid app. Hear the reason behind the recall and how it affects patients.  Medtronic's CEO Geoff Martha presented at the J.P. Morgan Conference this week and said the company is committed to prioritizing the restoration of its earnings power in the new year. Kirsh and Whooley some of Medtronic's target growth areas and how executives feel going into the new year.

Today's episode is a roundup of some of the most impactful medtech headlines of 2023. We had a handful of news stories this year that caught our attention. Join Fast Five hosts Sean Whooley and Danielle Kirsh as they discuss the following: Layoffs – Medtech has shown some resilience in the present economic environment. Some major medical device companies released positive earnings this year. However, others announced headcount reductions, citing macroeconomic headwinds. Hear which companies reduced their workforce the most in 2023 and some of the reasons they listed for the reduction. Personnel moves – Contrary to layoffs, some big names in medtech executive leadership also left their posts for new jobs in 2023. Some of our top stories were about CEOs leaving for a new company, retiring or another reason. Whooley and Kirsh discuss some of the largest personnel moves that shook the industry this year, including J&J MedTech's leadership change. Silicon Valley Bank closure – Silicon Valley Bank's closure in March affected several medtech companies. SVB has been a huge name in the tech and startup world since its founding in the 1990s. The Fast Five hosts talk about the companies that were backed by SVB and the surprising story of a medtech company that benefitted from the closure. Mergers & acquisitions – Medtech had some pricey acquisitions in 2023. Despite some macroeconomic challenges, M&A activity was seemingly up for the year. Hear about one of the largest deals of the year and some of the other deals in medtech in 2023. Brain-computer interfaces – Many companies joined the playing field for that technology or had breakthroughs in 2023. Blackrock Neurotech, BrainGate, ClearPoint Neuro, Neuralink, Synchron and more race to bring brain-computer interface (BCI) tech to market. Learn about the top companies in the BCI space and what their technology does.

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here's what you need to know for today, December 14, 2023. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Ekso Bionics announced it earned a Medicare win for its exoskeleton technology this week. Fast Five hosts Sean Whooley and Danielle Kirsh discuss what the win means for the company and the technology it is developing.  Calyxo closed a $50 million funding round to support kidney stone treatment. Hear how much funding the company has received in recent years and what the company's technology does. Tandem Diabetes Care has launched its diabetes management platform for insulin pump users. Whooley talks about what the new platform is designed for and some other positive news from the company in recent months.  Former Johnson & Johnson MedTech head Ashley McEvoy has landed a board position at a consumer goods giant. Learn where she is joining the board in today's episode.  Integra LifeSciences is buying J&J's Acclarent and its ENT technology. Whooley and Kirsh discuss the financial details of the deal and how it will supplement Integra LifeSciences' portfolio.

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here's what you need to know for today, December 6, 2023. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Rockley Photonics has begun sampling its biosensing wearable. Fast Five hosts Danielle Kirsh and Sean Whooley discuss what the wearable will measure, some of the design components and how optimistic executives are feeling.  EndoQuest raised $42 million for its endoluminal robotic technology. Learn what the funds will go toward and what technology EndoQuest is developing.  Johnson & Johnson's Ethicon has settled its remaining Physiomesh lawsuits. Whooley goes over what the judge on this case decided, how many cases Ethicon has been dealing with and what its response was to the judge's decision. Exactech won FDA clearance for its new ankle surgery navigation system. Hear what the system is designed for and what doctors think about the system's performance in today's episode.  Johnson & Johnson MedTech thinks new products will fuel growth for the company. Whooley and Kirsh discuss where J&J MedTech stands in the medtech market, what the new leader sees for the future of the medtech segment and what will drive value in the future.

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here's what you need to know for today, Devember 5, 2023. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Intuitive Ventures brought in another $150 million in funding to support minimally invasive care startups. Fast Five hosts Sean Whooley and Danielle Kirsh discuss Intuitive Ventures' background and what its goal is for improving care. Aptar won an FDA contract to study low global warming potential metered dose inhalers. Learn more about this initiative and how Aptar will support the FDA in this episode. GE HealthCare and AirStrip are partnering on patient monitoring and cardiac data visualization. Whooley explains what each company brings to this collaboration and what AirStrip's technology does. Nevro announced it acquired joint fusion device maker Vyrsa and closed a credit facility and refinancing. Hear more about the acquisition, including how Vyrsa supplements Nevro's portfolio. Three medtech companies issued warnings or recalls on some infusion pumps. Kirsh and Whooley talk about the three separate issues and how they all differ. Read more about BD's recall, Baxter's warning and Eitan Medical's recall.

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here's what you need to know for today, November 30. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Zilia this week won an FDA 510(k) clearance for a retinal camera. Fast Five hosts Danielle Kirsh and Sean Whooley explain what the retinal camera is designed for, how it works and what's next for the company.  ReValve reported one of the first successful first-in-human implants for its next-gen transcatheter mitral valve replacement. Hear about the procedures and what doctors thought about using the valve replacement. BiVacor received investigational device exemption from the FDA to begin feasibility studies of its artificial heart. Whooley details the technology that goes into the artificial heart and some of the plans behind the upcoming studies.  The first patient was enrolled in Penumbra's study of its computer-assisted vacuum thrombectomy system. Learn more about the system in today's episode and what this trial will evaluate.  Philips has announced thermal issues with some of its DreamStation 2 CPAP machines. Kirsh and Whooley talk about the latest warning from the FDA, the risks involved with using the device and Philips' response.

Artem Tepler sadly passed away on November 2nd, 2023. He visited me in Fort Worth and I'll never forget it. He was funny, and kind, and had a servant's heart. His story was infectious. I know he loved his daughter more than anything. That made up most of our conversation at lunch. Pray for Artem and his family. If you're able to give, there is a GoFundMe set up for his daughter, which can be found here: https://www.gofundme.com/f/artem-tepler On this episode, I am joined by Andrew Kirsh and Zack Streit. Andrew is an experienced commercial real estate transactional attorney, whose clientele includes a broad spectrum of national, regional, and local investors, funds, developers, operators, syndicators, private equity providers, and lenders. Andrew's practice involves all aspects of the real estate industry, including acquisitions, dispositions, equity investments, syndications, fund formation, development, leasing, financing, note purchases, and foreclosures. Zack has 15 years of multifaceted commercial real estate investment and advisory experience, including as an equity capital provider, a debt capital provider, and a capital advisor. His 8 years of institutional principal investment experience laid the foundation for a career as a capital advisor, where he has co-founded a capital advisory platform and closed billions of dollars in commercial real estate ventures.  We discuss: Personal Guarantees Personal vs. Non-recourse loans What to do when a deal and loan goes bad Foreclosing on a personal guarantee Filing for bankruptcy Links: GoFundMe for Artem's daughter Andrew on Twitter Zack on Twitter SklarKirsh WAY Capital Topics: (00:00:00) Intro (00:01:42) Personal Guarantees (00:10:57) Personal vs. non-recourse loans (00:20:14) How lenders are treating covenants in today's environment (00:25:03) Lookback periods (00:31:18) Capex Busts (00:33:41) Is the banker really my friend? (00:37:28) What to do when a loan goes bad (00:57:54) Deciding to foreclose when you have a personal guarantee (01:00:36) Filing for bankruptcy (01:09:46) Final Thoughts We'd appreciate you filling out our audience survey, so we can continuously work on providing relevant content to our listeners.  https://www.thefortpod.com/survey Chris on Social Media: Twitter: https://bit.ly/3BYIjcH LinkedIn: https://bit.ly/45gIkFd   Watch The Fort on YouTube: https://bit.ly/3oynxNX Visit our website: https://bit.ly/43SOvys Leave a review on Apple: https://bit.ly/45crFD0 Leave a review on Spotify: https://bit.ly/3Krl9jO  The FORT is produced by Johnny Podcasts

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here's what you need to know for today, November 7, 2023. Check out the show notes for links to the stories we discuss today at MassDevice.com/podcast. HistoSonics scored a reimbursement win for its sonic beam therapy. Fast Five hosts Danielle Kirsh and Sean Whooley explain what this means for the company and what the therapy is designed to do.  Johnson & Johnson's Ethicon announced an AI-powered laparoscopic training technology at a recent conference. Hear what the technology does, what the platform offers and what executives are saying.  Asensus has initiated a Senhance program in Germany, expanding further in Europe. Whooley explains some of the companies previous program announcements and the optimism that executives have.  Siemens Healthineers Diagnostics is laying off hundreds of employees in the U.S. The Fast Five hosts discuss the reason behind the layoffs and what Siemens Healthineers had to say about them.  A cyber gang threatens to release Henry Schein's data in a ransomware attack. Kirsh and Whooley talk about the details of the hack, including what the cyber gang is requesting in exchange for not releasing the data.

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here's what you need to know for today, October 31, 2023. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Cardio Flow this week announced the first commercial cases using its Freedom Flow device and appointed a new chief operating officer. Fast Five hosts Sean Whooley and Danielle Kirsh discuss what the device does, as well as the new executive appointment and some of their career history.  Cognito Therapeutics appointed a new chief commercial officer this week. Whooley goes over the new appointee's career history, their optimism upon joining the neuromod tech developer and what other executives think. The FDA has cleared a non-invasive insomnia treatment device from Neurovalens. Find out what this device is, how it works and what executives think about the future of the device.  The FDA is also warning about some over-the-counter eye drops. Whooley and Kirsh talk about what the warning covers, what products are affected and what the FDA is recommending customers and businesses carrying the eye drops do. A new report from the Pittsburgh Post Gazette and ProPublica said that Philips CEO Roy Jakobs approved the continued sale of defective sleep respiratory devices. Hear what the report claimed, what lawyers think and the statement given to Whooley from Philips about this report.

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In this week's episode, Qiagen CEO Thierry Bernard gives us a look inside the diagnostics leader both today and a few years ago when it was responded to the world's dire need for diagnostics. Bernard takes us back to the early days of the pandemic, including his perspective on how different countries responded to the crisis. We'll also hear his vision for the future of diagnostics including how Qiagen will make testing even simpler. At the start of the show, Host Tom Salemi and Chris Newmarker, executive editor of life sciences, talk with Senior Editor Danielle Kirsh about the recently released Women in Medtech issue of Medical Design and Outsourcing magazine. Kirsh shares data she's collected on how many women hold senior positions in the medical device industry. We're seeing some progress, but not enough. Thanks for listening to the DeviceTalks Weekly Podcast. Subscribe to the DeviceTalks Podcast Network on any major podcast player.

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here's what you need to know for today, October 13, 2023. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Orthofix launched its OsteoCove bioactive synthetic graft. Fast Five hosts Danielle Kirsh and Jim Hammerand discuss the features of the device and what executives are thinking about the launch. Medtronic won CE mark approval for its Evolut FX TAVI. Hear what doctors think about the device and what makes it unique compared to other devices in the Evolut portfolio. Getinge is making an infection prevention play with its latest acquisition of Healthmark. Get the financial details of the detail and how it will help Getinge's business in the long run. A judge has granted preliminary approval to Philips' class action settlement. Kirsh and Hammerand talk about the financials behind the settlement and what lawyers are saying. The EU has ordered Illumina to divest and unwind its merger with Grail. Listen to today's episode to hear about what the EU ordered and why the European Commission came to that decision.

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here's what you need to know for today, October 12, 2023. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Novo Nordisk has announced that it acquired all shares of drug delivery device maker Biocorp. Fast Five host Danielle Kirsh and guest cohost Jim Hammerand discuss the deal, including when the acquisition talks began. Ambu named its new chief financial officer for 2024. Find out who is taking over and what some of their career history is that supports this appointment.  The FDA has approved a next-gen intrathecal drug delivery system from Medtronic. Kirsh and Hammerand talk about the technology and what sets it apart from previous iterations of the device.  Medtech Innovator announced the 2023 Grand Prize winner at AdvaMed's Medtech Conference in Anaheim. Hear who the winner is and what their technology does in today's episode.  Boston Scientific won an expanded indication for its spinal cord stimulation system. The Fast Five hosts talk about the technology, some of the features and the optimism that executives have after this approve. Bonus: Sean Whooley brings his insights from the AdvaMed Medtech Conference. His biggest takeaway from Day 2 is about building innovative business models and disruptive technologies, as well as what big companies are thinking about mergers and acquisitions. Tune in to hear what he had to say and check out the rest of his coverage on MassDevice here.

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here's what you need to know for today, October 11, 2023. Check out the show notes for links to the stories we discuss today at MassDevice.com/podcast. Hyperfine received FDA 510(k) clearance for its artificial intelligence software for improve image quality on its Swoop portable MRI system. Fast Five host Danielle Kirsh and guest host Jim Hammerand discuss the latest software development and how it updates that MRI system. Medtronic is warning on some of its previous software on some MiniMed 780G devices in Germany. Find out what the issue is and how patients could be affected. The FDA wants more testing from Philips in the ongoing recall of its Respironics respiratory devices. Kirsh and Hammerand talk about why the FDA wants more testing from Philips and what Philips plans to do to address that. Reuters is reporting that Boston Scientific is opening its first factory in China. Hear what the report said and why the company is making a major play in China. Haemonetics is strengthening its cardiology device portfolio with the acquisition of OpSens. Kirsh gives the financial details behind the deal and how OpSens' devices will improve Haemonetics' existing portfolio. BONUS: Sean Whooley is on the ground at AdvaMed's Medtech Conference in Anaheim, California this week and he gives us one major takeaway from the talks he has sat in on so far. Hear how digital health is hitting a boom.

In this episode, we are joined by Elana Kirsh. Elana is the CEO of The Cannigma. The Cannigma takes an evidence-based approach to every issue surrounding cannabis – from safety to cooking to medical research – and makes all of that information digestible and useful. Topics: 1. The Cannigma Story 2. Advancing Policy Changes * Twitter - @TheCannabisRev2 * LinkedIn - @thecannabisreview * Episode Library - https://www.thecannabisreview.ie + The Cannigma https://cannigma.com/

In this captivating episode of the "In Search of More" podcast, our esteemed guest, Yakov Kirsh, host of the YouTube Channel @consciousjudaism, engages in a thought-provoking discussion with host Eli Nash, shedding light on his concept of 'Conscious Judaism.' Yakov candidly shares his personal journey, recounting the challenges he faced with Judaism during his upbringing, and how these conflicts led him to question his relationship with spirituality. He delves into his quest for understanding, which has led him to explore historical texts and the teachings of revered figures within Judaism. Through this exploration, Yakov highlights the evolution of teachings over time and the disparities between the original wisdom of elders and contemporary interpretations. ------------------------------------------------------------------------------------- Subscribe to the In Search of More Podcast: www.youtube.com/@InSearchOfMore?sub_confirmation=1 For booking inquiries, email: booking@insearchofmorepodcast.com Join Our WhatsApp: https://wa.me/message/PBH5QDJQNQ5LJ1 ------------------------------------------------------------------------------------- Follow us on social media Facebook | http://bit.ly/3jr9eYT Instagram | http://bit.ly/3JsvU5I TikTok | http://bit.ly/3XZ60Lo Twitter | http://bit.ly/3XNgxsR ------------------------------------------------------------------------------------- Connect with Yakov YouTube | https://bit.ly/3ZsDWBA Website | https://bit.ly/48vnpAL ------------------------------------------------------------------------------------- Connect with Eli Website | https://bit.ly/eliyahunash Instagram | https://bit.ly/eliyahu_nash Facebook | http://bit.ly/3h3rFSr YouTube | https://youtube.com/@insearchofmore ------------------------------------------------------------------------------------- Produced by Scarlett Row LLC Executive Producer Ryan Carter | https://bit.ly/3h0P1bm Intro audio purchased through Envato: Opener Intro Trailer Teaser by Florews --- Support this podcast: https://podcasters.spotify.com/pod/show/in-search-of-more/support

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here's what you need to know for today, September 22, 2023. Check out the show notes for links to the stories we discuss today at MassDevice.com/podcast. There are more funding raises in the news this week. The first one is from MedTrace, which raised $19 million for its PET-boosting technology. Fast Five hosts Sean Whooley and Danielle Kirsh go over what the funding will go toward and the technology they're developing. ProSomnus is raising $10 million for its CPAP alternative. Find out what the technology is and how optimistic executives are about the future of the technology. Whooley details a regulatory nod for Quantum Surgical's surgical robot in China. Hear about what the robot does, what kind of treatment it offers and what executives think about the regulatory nod. Medtronic Diabetes is having a good year – its Simplera CGM in InPen just won CE mark approval. Whooley and Kirsh discuss what technology and when Medtronic expects to launch the CGM. Hologic and Bayer have announced a partnership to improve mammography imaging. The Fast Five hosts go over the goal of the partnership and how the company plans to meet that goal.

We've got a good one for you today, the heavyweight edition. Today we're going to be talking about the role of sustainable infrastructure in private credit. And in particular, how it applies in an insurance framework. And we're joined by a serious panel here. We've got Brad Dyslin, who is the executive vice president and global chief investment officer, and also president of Aflac Asset Management. And we're also joined by the person who was in the seat prior to you, we've got Eric Kirsch, who is the former executive vice president, global chief investment officer, and president of Aflac Asset Management. And last but certainly not least, we're joined by Justin DeAngelis, who is the partner and co-head of sustainable infrastructure at Denham Capital. 

Axogen this week announced it launched its AxoGuard HA+ nerve protector. Fast Five hosts Sean Whooley and Danielle Kirsh share details on what AxoGuard is and why it is essential from a doctor's perspective. The surgical robotics space is expanding. Ronovo Surgical announced it raised $26 million in capital for its surgical robotic platform. Whooley explains what the surgical robot is designed for, what it gives surgeons and what Ronovo Surgical plans to do with the raised capital. Restor3d's acquisition of Conformis is finalized. Kirsh and Whooley discuss some of the deal's financial details and what executives think about the value-add.  Another trending space in medtech is brain-computer interfaces. Synchron announced this week that it completed patient enrollment in its new BCI trial. Find out the details of the trial, including the study's primary goal, and who are some of the other major players in the BCI space. Illumina has appointed a new CEO amid its SEC investigation. Whooley reveals who is taking over the corner office, some of their career history, and the challenges for the new CEO. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

Aion Biosystems announced this week that it won FDA 510(k) clearance for its iTempShield device and software system. Fast Five hosts Sean Whooley and Danielle Kirsh discuss what the system is, how it works and what executives are saying about the FDA clearance. Over-the-counter Narcan just became available with Emergent BioSolutions' recent launch. Find out about the company's FDA approval to get to this point and how it will become available to consumers.  Myomo has closed a $4.4 million public offering. In today's episode, Whooley details the offering and what the company plans to use proceeds for, including potentially expanding its employee count. Cardinal Health has launched its next-generation neonatal feeding device to reduce NICU stays. Discover how the system works, how it helps clinicians and what executives are saying about the launch. The legal proceeding with 3M and its combat earplugs has reached a $6 billion settlement. Whooley and Kirsh go over the breakdown of the payments like how it plans to pay and how the agreement was structured for the settlement.  Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

Anika Therapeutics received the final FDA 510(k) clearance for its Integrity implant system for improving outcomes in rotator cuff repair procedures through biologic healing. The hyaluronic acid-based patch augments an injured tendon, promoting rotator cuff healing. Fast Five hosts Sean Whooley and Danielle Kirsh delve into how the device works and what the regulatory nod means for Anika. Ventricular assist devices save lives and another one may soon be entering the fold. MagAssist won FDA breakthrough device designation for its NyokAssist VAD, which provides mechanical circulatory support for high-risk percutaneous interventions. Find out what led the agency to grant this designation. Axonics will soon have a new chief financial officer after longtime executive Dan Dearen notified the company of his intent to retire. The company already picked a replacement, promoting from within to fill the role. Learn more about Axonics' selection and what the new executive brings to the company in terms of experience and know-how. In another executive change, Tandem Diabetes Care announced that its chief commercial officer plans to resign from the role. Brian B. Hansen had been the company's CCO since 2016. Whooley and Kirsh take a look at Hansen's background and the terms of a separation agreement struck between Hansen and the automated insulin delivery technology developer. For the third time in as many months, Abiomed issued a correction for its Impella heart pumps. The FDA Class I recall pertains to the instructions for use for the system. The hosts break down the numbers behind this recall and what kind of mitigations Abiomed is implementing to remedy the issue. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

CathVision this week announced the FDA clearance of its PVI Analyzer and Signal Complexity algorithms for facilitating electrogram interpretation. The regulatory nod makes these artificial intelligence-based tools available to physicians. Fast Five hosts Sean Whooley and Danielle Kirsh explain what the algorithms are used for and what sets them apart from traditional EP recording systems. AngioDynamics received FDA breakthrough designation for its AngioVac system. The designation includes proposed indications for the use of AngioVac in the non-surgical removal of vegetation from the right heart. Find out what the company plans to do with the breakthrough nod and what executives see for the future of AngioVac. Tivic Health is planning to begin its vagus nerve stimulation trial after receiving Institutional Review Board (IRB) approval. Whooley shares details of the study, what the IRB approval means for Tivic and what the company hopes to achieve in the study. New data from a two-year trial of Nevro's spinal cord stimulation trial demonstrated durable pain relief and significant improvements in health-related quality of life. Learn some of the data points from the study and what doctors think about the results of the trial in today's episode. Medtronic's Mahurkar hemodialysis catheters are facing their third Class I recall. More than a million Mahurkar catheters have been recalled since July 2022. Whooley and Kirsh share the issue in this recall and how many devices are affected. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

Artificial intelligence is making its way through the medtech industry. iCad recently announced plans to integrate Google AI into its ProFound Breast Health Suite for 2D mammography. Fast Five hosts Sean Whooley and Danielle Kirsh go over how the company wants to use AI and the details of its existing partnership with Google. A new study from Edwards Lifesciences offers potential support for people with hypotension. Results from a study showed that using Acumen HPI may help reduce the duration and severity of intraoperative hypotension in patients having non-cardiac surgery. Hear how the software works and the full results of the study in today's episode. Siemens Healthineers and SSM Health want to increase health equity in the U.S. Learn how the two firms aim to expand access to high-quality care and aid in training the next generation of healthcare workers and what executives are saying about the collaboration. Surgical robotics are a hot topic in medtech, and more new systems are slated to hit the market in the next few years. Asensus Surgical, in particular, is hoping for an FDA clearance of its Luna surgical robot in 2025. Whooley shares the progress the company has made to achieve that goal. The FDA issued a notice labeling another recall of Getinge subsidiary Datascope's Cardiosave pump as Class I. Kirsh and Whooley discuss the recall, including the problem that led to the recall, how many devices are affected and if there have been any reports of injury so far. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

Tivic Health this week announced that it priced a public offering of common stock. The company plans to use the net proceeds for working capital and general corporate purposes. Fast Five hosts Sean Whooley and Danielle Kirsh explain what the offering includes and give details on the upcoming special stockholder meeting. Masimo's SedLine brain function monitoring could improve brain monitoring during endoscopy, according to a new study. Find out the key details of the study and how it assesses sedation levels during procedures.  The FDA clearance of Abbott's Alinity h-series hematology system represents a significant milestone for the company, as it expands its product portfolio in the hematology diagnostics market. Whooley explains how the system works and its significance in the field of laboratory diagnostics.  Several of Biosense Webster's ablation devices won a new indication from the FDA. Hear which devices received the expanded indication for zero fluoroscopy workflow and how the company picked up this approval. By engaging patients directly, Stryker aims to educate them about the benefits of Mako robotic-assisted surgery in a new direct-to-patient marketing campaign. Whooley and Kirsh discuss the goal of the campaign and how Stryker will enact this marketing plan.  Check out the show notes for the links to the stories we discussed today at MassDevice.com/podcast.

Earnings season continues in the medical device industry. Hologic posted its Q3 results this week, and it was a mixed bag. Investors and analysts have questions about future margins. Fast Five hosts Sean Whooley and Danielle Kirsh review the company's performance and the analysts' views.  The FDA recently granted expanded indication to Teleflex's QuikClot Control+ hemostatic device. The expanded indication may allow Teleflex to target new clinical applications. Find out what the expanded indication covers, how it increases the device's versatility in treating different patient populations, and what executives say.  Abbott FreeStyle Libre 3 reader is now available and is covered by Medicare. The Fast Five hosts discuss how the FreeStyle Libre 3 reader works and how it pairs with Abbott's latest continuous glucose monitoring sensor. Gain insights into Abbott's pipeline activity and plans for the second half of 2023. Integra Lifesciences plans to resume manufacturing at its Boston facility just two months after it voluntarily recalled all tissue-related products made at the plant. Whooley explains why the company stopped manufacturing and how it has addressed the problems since the recalls, including the measures taken to strengthen leadership and project management.  The FDA has labeled Baxter's recall of some infusion pumps as Class I, the most serious kind. Kirsh and Whooley go over the issues behind the recall, how many devices are included and what resolution the company is offering.  Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

The recent collaboration between Henry Schein and Medpod signifies an increased focus on telehealth solutions and the integration of diagnostic technologies. Fast Five hosts Danielle Kirsh and Sean Whooley discuss how the Medpac system serves as a telediagnostic offering and the benefits it offers patients and providers.  Inspire Medical recently appointed a former AppliedVR executive as its chief medical officer. The move highlights the significance of medical leadership in driving strategic decisions. Hear who is taking on the new clinical role and what their career experience is that supports the appointment.  The successful implantation of Anteris Technologies' DurAVR THV in a valve-in-valve procedure showcases a significant milestone in transcatheter heart valve technology for the company. Whooley explains the significance of the implant and what makes it unique compared to other transcatheter aortic heart valves. Augmedics' strategic acquisition of digital health assets from Surgalign signifies a convergence trend of medical devices and digital health solutions. Find out how much Augmedics paid for the assets and how it expands business at the company. Abbott announced that it would withdraw all Trifecta heart valves from the U.S. market more than five months after Abbott and the FDA told health providers that the valves could deteriorate early. Whooley and Kirsh discuss what led to the discontinuance and the company's new focus in the heart valve market.  Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

LivaNova's Q2 performance and increased 2023 guidance indicate the company's ability to adapt to market challenges and capitalize on growth opportunities. The Fast Five hosts discuss the company's financial performance, which segment had the greatest growth and what the CEO had to say about the quarterly earnings. Olympus recently launched its EasySuite ES-IP system for procedure room visualization and integration in the U.S. Whooley explains some of the features and capabilities of the new system and the benefits of using the platform in medical procedures. The positive results from the feasibility study of Glucotrack's implantable continuous glucose monitoring (CGM) system showcase the potential of implantable devices to transform diabetes management. Hear the feasibility study results and the key differentiators of the CGM in today's episode. Teleflex's decision to acquire Palette Life Sciences reflects its strategic focus on expanding its urology product portfolio and enhancing its position in the urological care market. Whooley and Kirsh discuss the deal's value, the technology Palette Life Sciences develops and how Teleflex will incorporate the technology into its portfolio. The FDA said an Abbott recall involving its Amplatzer steerable delivery sheath is Class I, its most serious level. The Fast Five hosts explain how many devices are involved in the recall and if there have been any reports of incidents so far. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

Philips recently announced Q2 results and an update on the ongoing DOJ talks and layoffs. Industry analysts may discuss Philips' forward-looking plans to mitigate order intake volatility and maintain a competitive edge in the medical device market. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the quarterly results and what the current status of the ongoing consent decree. The launch of Biosense Webster's AFib mapping catheter signifies J&J's commitment to advancing cardiac ablation technologies for atrial fibrillation patients. Hear how the technology works, how it could benefit clinicians and what doctors and executives think about it. This week, Baxter announced it launched the PerClot absorbable hemostatic powder in the U.S. Whooley shares the technology behind PerClor and how it enhances clinicians' abilities to optimize patient care. Inspire Medical Systems' selection of a former Medtronic executive as the new chief strategy officer underscores the ongoing talent mobility within the medical device industry. Find out who joins the respiratory therapy company's C-suite and what their career history has been to support the new role. J&J's decision to consider a split-off of Kenvue highlights the company's ongoing efforts to streamline its business portfolio and focus on core MedTech and pharmaceutical segments. Whooley and Kirsh discuss the details of the planned exchange offer, what shareholders could receive and what percentage of outstanding shares are up for grabs. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

Abbott has now seen two quarters in a row of double-digit organic sales growth in its underlying business. Now the company is betting on its productive, innovative pipeline to build momentum. Fast Five hosts Sean Whooley and Danielle Kirsh go over the full performance of the company and how each of its segments performed. Johnson & Johnson MedTech posted revenues of $7.9 billion, marking a 12.9% improvement year-over-year. Learn what the growth drivers were for the MedTech segment and what analyst's think about the second-quarter results.  The initiation of Magnus Medical's neurostim trial marks a significant milestone in the field of mental health treatment, offering hope for patients with treatment-resistant depression. Whooley and Kirsh discuss the company's technology and the potential impact it could have on the treatment of treatment-resistant depression.  MediView XR announced this week that it received FDA 510(k) clearance for its XR90 augmented reality-based visualization and navigation platform. Find out the purpose of the AR platform and how it works to address the limitations of traditional medical imaging technologies. Johnson & Johnson's Abiomed unit issued another recall for some of its Impella heart pumps. The recall is for TAVR-related devices. Whooley explains the reason for the recall, the risks involved and provides comments from Abiomed on the situation.  Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

Aetna's policy update expanding access to Neuronetics NeuroStar represents a positive step towards increasing patient accessibility to innovative depression treatment options. Fast Five hosts Sean Whooley and Danielle Kirsh explain what NeuroStar is and the policy update that expands access to the technology. Biostrap announced that it launched its new Kairos wearable device for data visualization of the autonomic nervous system. Such devices can potentially empower individuals to monitor their health metrics in real time. Hear how the technology works and what the company is doing for diagnostics for the nervous system. Ascensia Diabetes Care's deal to integrate blood glucose monitors in point-of-care testing reflects the importance of seamless data integration in diabetes management. Whooley details the partnership with Avricore Health and what kind of impact it will have on diabetes care delivery. Teleflex's completion of enrollment in a percutaneous coronary intervention study signifies progress in cardiovascular research. Find out more about the study and why it is important in treating coronary perforations in today's episode. Masimo's adjustment of its 2023 healthcare sales guidance and cost-cutting efforts underscore the dynamic nature of the medical device industry.Whooley and Kirsh go over the reasons cited by Masimo for the potential reduction in sales guidance and analysts' perspectives on the company's challenges and its potential impact on the broader medtech industry.  Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

The appointment of a former Medtronic executive as CFO of ForSight Robotics brings valuable industry experience and expertise to the company's leadership team. Fast Five hosts Sean Whooley and Danielle Kirsh discuss who was appointed and why the company decided to appoint them. Philips' enrollment of the first patients in a stroke diagnosis and treatment trial showcases the company's commitment to advancing stroke care and improving patient outcomes through clinical research. Listen to today's episode to find out what the trial will evaluate and what executives think about the trial. Drug delivery technology developer Eitan Medical announced this week that it appointed Shaul Sharoni as its new chief financial officer. Whooley goes over Sharoni's career background and how his appointment will contribute to the company's growth and long-term success.  The successful completion of the first procedures using Endologix's Detour system marks a significant milestone in the company's U.S. launch, offering a promising treatment option for patients with vascular conditions. Kirsh and Whooley detail the technology, where the rollout began and how optimistic executives are about the first procedures.  Medtronic's recent Class I recall affects certain implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). Find out which brands are affected and if there have been any reported incidents so far.  Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

Tivic Health's successful pricing of a $2.1 million offering reflects investor confidence in the company's innovative medical device solutions. The offering comes just days after the company closed another $1.8 million offering of common stock. Fast Five hosts Sean Whooley and Danielle Kirsh discuss what the offer includes and when it will close.  The collaboration between Glaukos and Radius XR signifies the growing adoption of wearable diagnostics in ophthalmology, aiming to improve disease monitoring and personalized patient care. Hear more about the wearable diagnostic platform and the terms of the collaboration agreement.  IR-MED recently announced positive interim results from a clinical study of its PressureSafe noninvasive, handheld optical monitoring device. Whooley gives an inside look at some of the key findings of the study, as well as what the device does. Philips initiated a repurchasing program to cover certain obligations arising from long-term incentive plans. Learn about how much money is involved in the program and the timelines associated with it. The adoption of the Asensus surgical robot platform by a leading U.S. hospital for pediatric procedures showcases the expanding application of robotic-assisted surgery in specialized areas of medicine. Kirsh and Whooley discuss the surgical robotic platform and what makes it compatible with pediatric patients. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

Boston Scientific received FDA approval for image-guided programming software, advancing deep brain stimulation treatments for neurological conditions. Fast Five hosts Sean Whooley and Danielle Kirsh review what the software offers clinicians. Henry Schein recently secured a $750 million credit facility, fueling its growth and ability to provide quality products and services in the medical device industry. Learn about the credit facility's maturity, what executives are saying, and some of the busy strategic moves the company made earlier this week. Aerin Medical's treatment for nasal airway obstruction gained support with data validation, offering effective solutions for improved breathing and quality of life. Whooley and Kirsh discuss what VivAer is and some of the key data points from the study and what doctors think of the device.  Inogen recently expanded its respiratory care portfolio by acquiring Physio-Assist, a French developer of airway clearance technology. Hear about Physio-Assist's business and what Inogen's rationale was behind the acquisition.  BD highlighted the importance of medical device cybersecurity, disclosing and addressing eight vulnerabilities in the Alaris infusion systems. The Fast Five hosts explain which devices are included in the vulnerabilities and the rocky history of Alaris pumps in the last few years. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

Olympus this week announced positive study data for its minimally invasive iTind treatment for enlarged prostate symptoms. Fast Five hosts Sean Whooley and Danielle Kirsh go over what that treatment option is, how it works and what some of the study results showed.  Eitan Medical's launch of a cloud-based infusion management platform reflects the integration of digital technologies into healthcare, aiming to enhance patient safety and optimize medication administration. Learn more about what Eitan Insights is and what the company designed the technology for in today's episode.  Urotronic designed Optilume as a minimally invasive surgical therapy to alleviate urinary symptoms caused by BPH – and the FDA approved its use this week. Whooley explains what the technology does and how optimistic executives are after news of the approval.  FDA's updated guidance on paclitaxel-coated devices provides important insights into the ongoing evaluation and monitoring of device safety. Hear about why it updated the guidance and the recommendations for provider action with the new guidance.  The EU's significant fine imposed on Illumina over the Grail deal highlights the increasing scrutiny and regulation within the medtech industry, particularly regarding mergers and acquisitions. Whooley and Kirsh discuss why the fine was issued, as well as a brief history of the acquisition and what Illumina plans to do next. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

Heart failure is a prevalent condition that requires effective management and monitoring to improve patient outcomes and quality of life. Shifamed portfolio company Adona Medical recently introduced its next-generation heart failure platform. Fast Five hosts Sean Whooley and Danielle Kirsh detail the technology that is featured in the system and how it works to enhance patient care. The FDA clearance of Tandem Diabetes Care's Mobi durable automated insulin pump reflects the ongoing advancements in diabetes management and the integration of technology into treatment options. Learn how Tandem's new technology differs from its existing platforms and how it stacks up against other competitors already on the market. Stryker announced this week that it launched its Q Guidance System with cranial guidance software. This launch comes on the heels of last week's Ortho Q fully autonomous guidance system launch. In today's episode, Whooley explains what the system is designed for and some of the technology behind the guidance software. ECG interpretation software can assist healthcare professionals in analyzing electrocardiogram results, potentially aiding in detecting and diagnosing cardiac abnormalities. The FDA cleared AccurKardia's ECG interpretation software just this week. Hear about the features and benefits of the system and the clinical data that support its use in this episode. The FDA labeled a recall of Megadyne electrode products manufactured by Johnson & Johnson's Ethicon Class I, the most serious kind. Whooley and Kirsh discuss the reason behind the recall, how many devices are affected and if there have been reports of injury from use of the devices. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

The FDA clearance of Getinge's non-invasive mechanical ventilator showcases the ongoing efforts to develop advanced respiratory devices that can provide critical support to patients in need. Fast Five hosts Sean Whooley and Danielle Kirsh detail what the ventilator does and when patients can expect the ventilators to hit the market. PainTEQ's successful fundraising round will expand the commercialization of its LinQ implantable sacroiliac (SI) joint stabilization system. Whooley explains the technology behind the device and the company's success in previous procedures using the device. Chief financial officers play a crucial role in driving financial strategies, ensuring regulatory compliance, and supporting business growth and sustainability, and Fresenius Medical Care appointed a new one to its executive team. Hear how the appointee's career history supports their appointment and how optimistic executives are in today's episode.  The U.S. Federal Trade Commission wants to have a say in Applied Medical Resources' antitrust lawsuit against Medtronic. Whooley and Kirsh discuss the ongoing lawsuit, why Medtronic wants to dismiss the lawsuit and what the FTC has to say about it. The decline in Outset Medical's stock following the receipt of an FDA warning letter demonstrates the impact that regulatory compliance and product quality have on investor confidence. The Fast Five hosts discuss the details in the warning letter and if it will affect Outset Medical's production of devices. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

Microbot Medical's completion of a pre-clinical study for its endovascular surgical robot signifies a significant milestone for the company. Fast Five hosts Danielle Kirsh and Sean Whooley explain what the surgical robot does and what the outcome of the pre-clinical study was. The FDA clearance of Boston Scientific's Embold Soft & Packing coils demonstrates the company's commitment to expanding its portfolio of innovative solutions for embolization procedures. Hear about what the coils are designed for and how it streamlines hospital workflows on today's episode. Integra Lifesciences' completion of enrollment in the DuraSorb monofilament mesh IDE study is a significant step toward gathering valuable clinical data for this product. Whooley details what the study will evaluate and how optimistic are executives at the company. Federal prosecutors claim a former DePuy Synthes sales representative defrauded an undisclosed Boston area hospital, with hundreds of thousands of dollars worth of spine products involved. Kirsh and Whooley share what the sales representative is accused of, how it allegedly benefitted the sales rep and DePuy Synthes' response.  The resignation of NeuroPace's CEO and the appointment of a former Integer executive as his successor mark a significant leadership change within the company. Whooley and Kirsh discuss the details behind the resignation and who is taking over the corner office. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

Sernova's positive interim data for the Cell Pouch System highlights the potential of regenerative medicine in addressing various medical conditions. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the key findings in the data in today's episode. Ultra-low frequency neuromodulation has the potential to revolutionize the field by offering more precise and targeted treatment options. Presidio Medical recently raised $72 million for its ultra-low frequency neuromodulation, and Whooley has all the details on the fundraising. Augmedics' successful funding round and milestone of treating 4,000 U.S. patients with Xvision underscore the growing adoption and impact of augmented reality (AR) in surgical procedures. Hear how the Xvision technology works and why this was a significant capital raise. Teleflex issued a Class I recall of its Arrow Endurance extended dwell peripheral catheter system. The Fast Five hosts provide more details about how many devices are affected and how many complaints there have been so far. Boston Scientific elected Dr. Jessica Mega and Susan Morano to its board of directors. Whooley and Kirsh explore the appointees' career backgrounds and what CEO Mike Mahoney said about the appointments. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

In which Dan talks with Celeste Kirsh, middle school educator, podcast host, and Ph.D. student. Celeste is a deeply reflective and thoughtful person, and so Dan picks her brain about digital media literacy, teaching young people to write, and why we should be hopeful about the future. As always, I welcome comments and questions on Twitter and Instagram @bigideaedFeatured on the show and further reading:Teaching Tomorrow Podcast, produced and hosted by Celeste KirshCivix CanadaCountering Truth Decay by RAND (a report on digital literacy)"How ChatGPT robs students of motivation to write and think for themselves" by Naomi Baron"ChatGPT will fundamentally change how we teach writing; that's a good thing" by Christopher Mah"ChatGPT and Writing Assessment, an Old Problem Made New" by John WarnerConference to Restore Humanity from Human Restoration Project*Enter promo code BIGIDEA at checkout for a $25 discount*Music by Stars in LA

Continuous glucose monitoring (CGM) systems have revolutionized diabetes management by providing real-time data on glucose levels, and new data supports the safety and accuracy of Senseonics 365-day CGM. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the study's key findings. Aortic aneurysms pose significant health risks. The FDA's approval of Cook Medical's endovascular graft trial represents a positive development in treating this condition. Hear how Cook Medical wants to make the gold-standard treatment of aortic aneurysms easier.  Diabetes management is not limited to insulin users alone, and Dexcom's endeavor to develop a glucose sensor for non-insulin users reflects a commitment to inclusivity. Whooley explains what the technology will cover and how Medicare will cover the innovation. Medtronic's appointment of Greg Lewis as director adds another seasoned professional with extensive financial experience to the company's leadership team. The Fast Five hosts detail his prior experience and CEO Geoff Martha's thoughts. Mergers and acquisitions are common in the medical device industry as companies seek to enhance their product portfolios. Whooley and Kirsh outline Restor3d's plan to acquire Conformis, including when the transaction is expected to close and what executives at both companies are thinking. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

Teleflex's voluntary recall of its Rüsch endotracheal tubes highlights the possibility of oxygen desaturation, and in the event, any immediate or long-term health consequences depend on the degree and duration of desaturation. Fast Five hosts Sean Whooley and Danielle Kirsh share what issue caused the recall and how many complaints the company has received so far. The FDA's IDE approval of Metavention's renal denervation therapy represents an important milestone in the treatment of hypertension. Whooley details what the platform does, how it works and how optimistic executives are. Real-world data validating the efficacy and usability of Bigfoot Biomedical's diabetes management platform underscores its potential to revolutionize diabetes care. Kirsh and Whooley discuss some of the key data points from the study and the company's future plans. Insulet's ongoing efforts to integrate its Omnipod 5 system with Abbott's FreeStyle Libre 2 sensor marks a significant advancement in the company's diabetes management technology. Whooley talks about where the technology is currently integrated and plans for a clinical study in the future. The appointment of Lea Daniels Knight as CFO of Integra Lifesciences brings a seasoned financial leader to the company's executive team. Hear about her prior experience in finance and medtech and what the company's CEO has to say. Check out the show notes for links to the stories we discussed and more at MassDevice.com/podcast.

The partnership between Nuwellis and DaVita to launch an ultrafiltration therapy pilot program is an exciting development in the field of renal care. The agreement enables Nuwellis — formerly CHF Solutions — to pilot its Aquadex ultrafiltration therapy within selected U.S. markets. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the partnership in detail and what executives say about it. CorWave's successful fundraising of $64 million is a significant milestone for the company as it prepares to manufacture its left ventricular assist device (LVAD). LVADs play a critical role in supporting patients with advanced heart failure, and CorWave's technology has the potential to improve patient outcomes and enhance their quality of life. Learn more about the company's technology and other developments in today's episode. Avanos Medical's decision to acquire Diros Technology is a strategic move demonstrating the company's commitment to expanding its portfolio and addressing unmet needs in the medical device market. Diros Technology makes radiofrequency products that are used to treat chronic pain conditions. Whooley explains how the acquisition will support Avanos' offerings and when the transaction will be completed. The FDA approval of Surmodics' SurVeil drug-coated balloon highlights the continued advancements in interventional cardiology and the increasing availability of innovative treatment options for patients with peripheral arterial disease (PAD). Hear how the technology stacks up against other devices in the market and how the company overcame being "unapprovable" earlier this year. BD's decision to sell its surgical instrumentation assets to Steris for $540 million marks a strategic move to streamline its portfolio and focus on core areas of expertise. This transaction enables BD to allocate resources more effectively and invest in research and development efforts that align with its long-term growth strategy. Whooley and Kirsh explain how BD will expand and how the acquisition will affect Steris' bottom line. Check out the show notes and links to the stories we discussed today at MassDevice.com/podcast.

The release of positive 2-year data supporting the Endologix Detour system is significant news in the field of peripheral arterial disease (PAD) treatment. This data provides strong evidence of the system's long-term efficacy and durability in managing PAD, a condition that affects a significant number of individuals globally. Fast Five hosts Sean Whooley and Danielle Kirsh explore the data behind the study. Relievant Medsystems' positive data highlights the potential of nerve ablation as a minimally invasive and effective approach to pain management. By targeting specific nerves responsible for transmitting pain signals, this procedure may provide lasting pain relief and improve patients' overall quality of life. Whooley details what the device does and the results from the study, including what doctors think about the technology. The backing of Politan's nominees by Institutional Shareholder Services (ISS) in the ongoing board battle at Masimo is a notable development in the company's corporate governance. This endorsement adds an important dimension to the discussion and may have implications for Masimo's future leadership and strategic direction. Kirsh and Whooley discuss the board battle and the response from Masimo and the ISS on the matter. Recent layoffs at Siemens Healthineers in New Jersey signal a significant change in the company's workforce and operations. Workforce restructuring and optimization are common practices in the medical device industry, driven by various factors such as market dynamics and business strategies. Whooley gives more details about the layoffs, including how many people are affected, when the layoffs are effective and if there is any severance involved. A warning issued by Philips regarding the potential breakage issue with its Allura and Azurion systems raises concerns about patient safety and equipment reliability. The Fast Five hosts talk about the issue more in-depth and what Philips is doing to remediate the problem. Check out the show notes at MassDevice.com/podcast.

Another episode of the Fortnite Podcast is here. Twitch is crashing and burning. Follow Us On Twitter @FortnitePodcast MonsterDface - @MonsterDface Life With Panda - @LifewPanda  Checkout more MonsterDface content: YouTube - youtube.com/monsterdface  Twitch - Twitch.tv/MonsterDface Competitive Practice: Openscrims.com MonsterDface Website NEW Practice Server Website! Email us at FortnitePodcast@gmail.com 

The FDA clearance obtained by startup Ezra for its AI technology marks a significant milestone for the company. Ezra wants to reduce MRI times to 15 minutes. Hear more from Fast Five hosts Danielle Kirsh and Chris Newmarker as they outline what the technology does and its potential to streamline MRI scans. B. Braun recently launched its DoseTrac Enterprise infusion management software for hospital systems. The technology can connect up to 40,000 different infusion pumps at once. Get the details from Newmarker about how the technology helps hospitals reach significant results and how the mobility of the system increases efficiency. ABK Biomedical's FDA investigational device exemption (IDE) approval for tumor-treating microspheres is a significant development in the field of interventional oncology. This milestone enables ABK Biomedical to conduct clinical trials and gather crucial data on the safety and efficacy of their microsphere technology for the treatment of tumors. Kirsh and Newmarker describe the technology and how doctors think it could change oncology treatment. The recent FDA clearance obtained by Philips and Masimo will have a positive impact on their established partnership. The FDA clearance allows the companies to use SedLine brain function monitoring, Regional Oximetry and CO2 measurements in Philips' patient monitors, IntelliVue MX750 and MX850. Newmarker explains how the technology combination will help care providers act decisively. Bayer's strategic focus on digital health represents a significant shift in their approach to healthcare. By investing in digital health solutions, Bayer aims to leverage technology to improve patient outcomes, enhance healthcare delivery, and drive innovation across the industry. Kirsh and Newmarker share details about the potential play-in from Bayer, including what the company is currently investing in and what it plans to prioritize in its digital health shift. Check out the show notes at MassDevice.com/podcast.

The global release of Exactech's next-generation GPS Shoulder system marks an important milestone in shoulder arthroplasty. The launch, taking place in EMEA and APAC countries, follows the first surgery in the United Arab Emirates earlier this month. Fast Five Hosts Danielle Kirsh and Chris Newmarker share details about the orthopedic device and what doctors think of the system. With a new CE mark, Establishment Labs has completed a full transition of all currently marketed Motiva implants and tools, as well as the company's quality management systems, to be in compliance with the new European Medical Device Regulation (MDR). Newmarker explains the devices included in the new indication and what surgeons and executives think about it. The FDA's breakthrough designation for CardioRenal's Tenor at-home blood potassium measuring device signifies a significant advancement in monitoring and managing blood potassium levels in patients. This innovative device enables individuals to conveniently and accurately measure their potassium levels from the comfort of their own homes. Kirsh and Newmarker explain the benefits of at-home monitoring and how Tenor works. The clash between Masimo management and activist investor Politan has brought attention to the strategic direction and governance of the company. With differing perspectives on key decisions and company performance, this dispute highlights the challenges faced by organizations in managing shareholder expectations. Newmarker details the disagreement between the two parties and who on the board of directors is up for a vote. iRhythm's receipt of an FDA warning letter regarding its Zio AT quality systems highlights the importance of robust quality control measures in the medical device industry. iRhythm's response to the FDA warning letter and its actions to address the identified issues will be closely watched by regulators. Hear more about the warning letter from the Fast Five hosts.