Fast Five Medtech News Podcast

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, March 15, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Conformal Medical this week reported "encouraging" results for its left atrial appendage occlusion device. Fast Five hosts Danielle Kirsh and Sean Whooley discuss what the device does and what doctors think about the device. Autonomix has completed its first procedures in its pancreatic cancer ablation trial. Learn what the trial will assess, what the technology does and how optimistic executives are. Axonics won CE mark approval for its fourth-generation rechargeable sacral neuromodulation system. Whooley talks about what the device does and some of the other news Axonics has had recently. SafeGuard Surgical won an FDA breakthrough nod for its biodegradable stent. Hear more about the stent, which has backing from an NFL quarterback. Edwards reported "excellent" outcomes with its latest Sapien TAVR study. The Fast Five hosts talk about some of the data points that stuck out.

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, March 14, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Sooma raised $5.5 million for its depression-treating neuromodulation technology. Fast Five hosts Sean Whooley and Danielle Kirsh talk about what the company's technology does and what it plans are for the funds.  SetPoint Medical won FDA breakthrough designation for its nerve stimulation technology for multiple sclerosis. Hear more about the technology and the executives' optimism about the future of the technology.  Abbott is launching its latest Navitor TAVI system in the U.S. Whooley talks about the technology and Abbott's TAVR market history.  GE Healthcare has established a foundation to advance access to healthcare. The Fast Five hosts talk about what the new foundation will focus on and what the future holds.  A former Stimwave CEO was recently convicted of healthcare fraud. Learn more about what the CEO was found guilty of and how the case unfolded.

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, March 13, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. GE HealthCare and Mass General are bringing artificial intelligence to imaging. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the partnership and how it can transform healthcare. Ascensia and Senseonics have announced new CGM cost savings. Hear more about some of the cost saving initiatives and the devices that are included in the initiatives. SS Innovations has used its surgical robot in mitral valve replacement procedures. Whooley talks about what the robot does and what people think about its performance.  3M CEO Mike Roman is stepping down as CEO and a successor has been named. Learn who is taking over the corner office and the optimism they bring to the role. A recent recall of Abbott's HeartMate communications system is Class I, according to the FDA. The Fast Five hosts talk about the reason behind the recall and if there have been any adverse reports.

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, March 12, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Boston Scientific reported positive results for the agent drug-coated balloon study. Fast Five hosts Danielle Kirsh and Sean Whooley talk about the technology and the data points that stick out. Medtronic is highlighting the global performance of its MiniMed 780G automated insulin delivery system. Hear about what the new data highlights and some of the most compelling data the company highlighted. The FDA has cleared Pulse Biosciences' pulsed field ablation electrode technology. Whooley talks about what the PFA electrode technology does and some of the optimism that executives have. Onward was accepted into an FDA advisory program. The Fast Five hosts talk about the technology that got them into the advisory program and what the acceptance means. iRhythm closed an offering worth more than $660 million. Learn more about what is included in this offering and what the company plans to use the proceeds for.

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, March 8, 2024. Check out the show notes at MassDevice.com/podcast. Siemens Healthineers launched a new surgical planning tool. Fast Five hosts Chris Newmarker and Sean Whooley examine the latest application of surgical planning and education using the Apple Vision Plus system. Nanoflex Robotics announced the first U.S. installations of its surgical robot. The hosts take a look at what this robot does and how Nanoflex hopes to use it to improve the treatment of stroke patients. Biobot Surgical raised $18 million to support its surgical robot. Newmarker and Whooley break down the unique purpose of this company's surgical robot and discuss the potential uses of proceeds. Roche Diabetes Care unveiled its new CGM technology with predictive AI algorithms. The Fast Five hosts examine the properties of yet another potential competitor in the CGM market and see if the predictive AI capabilities could set it apart from the rest. The FTC is reportedly looking into Boston Scientific's acquisition of Axonics. Following a $3.7 billion acquisition, some questions have arisen around antitrust activity. Newmarker and Whooley look at Bloomberg's report on a potential investigation and break down the potential fallout if this acquisition doesn't go through.

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, March 7, 2024. Check out the show notes at MassDevice.com/podcast. Abbott reported some positive real-world data on the use of its CGM with GLP-1s. Fast Five hosts Chris Newmarker and Sean Whooley take a look at the emergence of GLP-1s in medtech and the potential to bolster CGM technologies. Gradient began a U.S. trial for its pulmonary denervation technology. With renal denervation garnering so much attention recently, the hosts examine another denervation technology for treating hypertension. Orthofix posted Street-beating fourth-quarter results. With tons of changes at Orthofix over the past year, analysts seem more positive about these latest results. The Fast Five hosts look at some of the key figures from the quarter and how Orthofix can right the ship. ResMed launched a new face mask for sleep apnea patients. With recalls all over the place in the sleep apnea market, including at ResMed, this could prove a significant launch. Newmarker and Whooley break down some of the history of the market and look at the standout features of this mask. The FDA cleared the first over-the-counter CGM, with Dexcom's Stelo getting the nod. Listen to hear all about this new technology and how it could provide a boost to many within the diabetes community.

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, March 6, 2024. Check out the show notes at massdevice.com/podcast. Medtronic may face a jury trial in a legal case over spine implants. Fast Five hosts Chris Newmarker and Sean Whooley break down the nearly decade-long history of this lawsuit and discuss the decision handed down by a judge in this case. Baxter has decided to close a facility in Massachusetts. Listen to learn all about Baxter's reasoning behind this facility closure and how it ties into a major acquisition made by the company a few years ago. Dexcom announced a new direct-to-watch feature for G7 CGM. The Fast Five hosts look at what this new feature is and examine some other good news from Dexcom. Stereotaxis submitted its Magic ablation catheter for U.S. and European approval. Find out more about this technology and hear about the company's intriguing fourth-quarter results as well. Haemonetics agreed to acquire esophagus-protecting device maker Attune Medical. Newmarker and Whooley discuss the technology that Attune brings to the table and how Haemonetics feels it will fit in as part of the company.

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, March 5, 2024. Check out the show notes at MassDevice.com/podcast. The FDA approved Boston Scientific's Agent drug-coated balloon. Fast Five hosts Chris Newmarker and Sean Whooley explain the significance of this approval and dive into why analysts think it's a major win for Boston Scientific. BD has initiated a new trial for its Vascular Covered Stent. Find out more about what the stent does and why BD thinks it addresses a significant unmet need. Phagenesis reportedly brought in $42 million in funding for its neurostimulation technology. The hosts take a look at what the technology actually is and what the British medtech company plans to do with its latest cash influx. Medtronic picked up FDA clearance for its latest-generation bone tumor ablation technology. Hear all about what sets this technology apart from the competition and from Medtronic's previous bone ablation system. Baxter has a major update on its planned Kidney Care spinoff. The Fast Five hosts break down a bit of a twist in Baxter's separation plans and discuss how it folds into a recent trend across the medtech space.

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, March 1, 2024. Check out the show notes at MassDevice.com/podcast. Orthofix this week appointed a new president of its Bone Growth Therapies business. Fast Five hosts Danielle Kirsh and Sean Whooley discuss who is joining the company and some of their career experience. Affluent Medical has positive biomimetic mitral valve data. Learn more about the valve and some of the data points that study out. Onward won an FDA breakthrough nod for use of neurostim with brain-computer interface. Whooley explains what the technology does and how this was a milestone breakthrough for the company. J&J's Biosense Webster's pulsed field ablation system won CE mark approval. Hear more about what its approved for and the data that led to this approval. Medtronic is asking the ITC to stop Axonics' sales of its neuromod devices. The Fast Five hoses discuss why Medtronic wants to stop the sales and the history of this spat.

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, February 29, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. A new report shows Insulet trumped Medtrum again in a French patent spat. Fast Five hosts Danielle Kirsh and Sean Whooley talk about what the spat was about and what the court ruled. Stryker has reported its first shoulder arthroplasty with the Blueprint MR guidance system in Europe. Hear more about those procedures and what doctors think about the technology. Osso VR has picked a new CEO as the former leader transitions into a new role within the company. Whooley explains who is taking over the corner office, some of their career history, and where the former CEO is transitioning into. Philips tapped a Stryker controller as its next chief financial officer. Learn who is taking over the financial role, their experience and what optimism they bring to the company. Integra Lifesciences' CEO Jan De Witte is set to retire. The Fast Five hosts talk about when he will step down and if the company is looking for a new CEO immediately.

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, February 28, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Mainstay Medical has raised $125 million for its neurostimulation technology. Fast Five hosts Danielle Kirsh and Sean Whooley talk about the company's plans for the funds and what the implant does. Philips has launched its new Azurion neuro biplane system for neurovascular interventions. Learn more about what Azurion does and how it helps workflows. Know Labs unveiled its wearable, non-invasive CGM set for FDA submission. Whooley details the technology and how it works.  J&J's Biosense Webster has started its trial for the recently acquired Laminar left atrial appendage elimination device. Hear more about the study details and an explanation of what Laminar is. A high-ranking executive at BD has announced plans to retire. The Fast Five hosts talk about who is leaving, if the company named a successor and some of the work the executive has achieved in their tenure.

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, February 27, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Owlet is set to raise $9 million to support its infant monitoring technology. Fast Five hosts Danielle Kirsh and Sean Whooley talk about the technology and some of the terms of the funding. GE HealthCare and Biofourmis are collaborating on at-home patient monitoring. Hear more about the goal of the partnership and how it will help patients. Irish startup Gasgon Medical is looking to raise €4 million for its IV delivery technology. Whooley explains the company's technology and what some of the funding will support. Virtual Incision won an FDA nod for its miniature MIRA surgical robot for use in colectomies. The Fast Five hosts discuss what the robot does and the pathway Virtual Incision took to get to this point. Integra Lifesciences has announced it is closing one of its plants. Learn about which plant is closing and how many people it affects.

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, February 23, 2023. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. ClearPoint Neuro's latest software received FDA clearance and the company announced the first cases. Fast Five hosts Danielle Kirsh and Sean Whooley talk about what the software does and what executives are saying. The FDA is warning people not to use smartwatches and smart rings to measure blood glucose. Learn why the FDA is warning on this and what consumers should do. Enovis's stock rose this week on Street-beating fourth-quarter results as it returns to profit. Whooley breaks down the financial performance of the orthopedic company. Zimmer Biomet's ROSA Shoulder surgical robot. The Fast Five hosts talk about what the surgical robot does and what it gives physicians. A former Mazor VP has been convicted of insider trading. Hear more about this case and how the federal government stumbled upon this case. BONUS: Jill Biden launches $100M initiative to transform women's health research

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, February 22, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. DarioHealth has acquired digital health company Twill and priced a $22.4 million private placement. Fast Five hosts Danielle Kirsh and Sean Whooley talk about what Twill does and how it helps DarioHealth. Sira Medical won an FDA nod for its augmented reality surgical planning technology. Hear what the technology does and the challenges the company hopes to address. Medical Microinstruments has raised $110 million to support its surgical robot. Whooley explains what the robot does and some of the other funding the company has garnered over the years. A Medtronic EVP is leading amid the company's latest reorganization. Find out who's departing, some of their notable achievements and who's taking on their role. 3M finally announced a date for its Health Care spinoff. The Fast Five hosts talk about what will happen on the spinoff date, how many employees transfer to the spinoff and the leaders that will take the helm.

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, February 21, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Better Therapeutics won an FDA breakthrough designation for its liver disease-treating digital therapeutic system. Fast Five hosts Danielle Kirsh and Sean Whooley talk about the therapeutic and how it earned the breakthrough nod. EnsoData won an FDA nod for its AI sleep diagnosis technology that uses pulse oximeters. Hear what sets this technology apart from other sleep apnea tracking technology. The FDA has cleared a wearable EP monitoring patch from X-trodes. Whooley explains how the technology works and what executives are saying about the future of the device. BioSig reduced its workforce for a second time in less than a month as it looks to 'substantially' cut operations. The Fast Five hosts talk about the reason behind the layoffs. Medtronic is exiting the ventilator market. Learn what the company plans to do with its existing respiratory business and how imperative ventilators were to Medtronic. BONUS: Read Danielle Kirsh's latest analysis of the medtech stock market in 2023 – How GLP-1s tanked and reshaped the medtech stock market in 2023: Analysts weigh in on how the GLP-1 craze caused one of the biggest swings in the medtech stock market in recent years.

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, February 16, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Sparrow BioAcoustics launched software that turns a smartphone into a stethoscope. Fast Five hosts Sean Whooley and Danielle Kirsh talk about how the software works and the visualizations it gives physicians. Medtronic has named its first chief sustainable officer. Find out who is taking on this newly created role. Enable Injections is expanding its manufacturing facilities to support drug delivery device production. Whooley explains the expansion effort and how it fits into the strategy of the company. The FDA cleared Merit Medical's surgical guidance system. Learn what the guidance system does and how it improves patient care. NeuroMetrix announced plans to review its strategic options. The Fast Five hosts explain what the company is considering and if there will be any changes to its commercial operations.

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, February 15, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Vessi Medical raised $16.5 million for cryotherapy for bladder cancer treatment. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the technology.  Think Surgical has entered into multiple surgical robot collaborations. Hear more details about the collaborations and what executives are saying. Pulse Biosciences reported positive 60-day evaluations for its atrial fibrillation-treating pulsed field ablation. Whooley details the PFA technology and what some of the early data is showing.  Impulse Dynamics raised $136 million for its heart failure therapy. The Fast Five hosts talk about what the funding will go toward and the technology the company is working on. An FDA panel voted in favor of Abbott's TriClip TEER system for treating tricuspid regurgitation. Learn more about the advisory panel vote and the analysts' view.

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, February 14, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Wandercraft won FDA clearance for its exoskeleton for people with spinal cord injuries. Fast Five hosts Sean Whooley and Danielle Kirsh explain the details of the exoskeleton and some of its features. The FDA has cleared Masimo's over-the-counter fingertip pulse oximeter. Hear more about what the device does and where it will be available. ResMed launched new bilevel sleep respiratory devices. The Fast Five hosts discuss the new devices and ResMed's goal when developing them. Smith+Nephew is touting new artificial intelligence features for its Cori surgical robot. Learn more about the latest features of the robot. Zimmer Biomet signed a health equity pledge. Whooley talks about the pledge and how the company is taking strides toward that goal.

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, February 13, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Senseonics earned an expanded Medicare coverage for long-term implantable CGM. Fast Five hosts Danielle Kirsh and Sean Whooley discuss the details of the new coverage allows for and what executives see for the future of the device. Osso VR has launched a controller-free option for its surgical training VR. Hear more about the option and how it differs from standard controls. Think Surgical and Link are collaborating on surgical robotics for total knee replacement. Whooley explains the goal of the collaboration and what executives are saying. Smith+Nephew has unveiled its expanded sports medicine portfolio. Learn what's in the expanded portfolio. Canary Medical had its first-in-human implant of its heart sound monitor. The Fast Five hosts talk about the technology and whether it has had any success so far.

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, February 9, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Baxter beat The Street in its fourth-quarter results as its kidney care spinoff progresses. Fast Five hosts Sean Whooley and Danielle Kirsh talk about the company's financial performance and how the spinoff is going. The FDA has cleared Fresenius Medical Care's 5008X hemodialysis system. Hear more about the hemodialysis system and what makes it different. CMR Surgical has enhanced its surgical robot with new imaging technology. Whooley explains the new imaging technology and how it helps doctors. Biosense Webster supports a duo of new studies using Varipulse pulsed field ablation technology. Learn what the studies will evaluate in today's episode. J&J's Cerenovus has launched a next-generation stroke revascularization catheter. The Fast Five hosts explain what the catheter is designed for, some of its features and what executives are saying.

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, February 8, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. ShiraTronics completed its implantable migraine therapy pilot enrollment and set up its U.S. clinical study. Fast Five hosts Danielle Kirsh and Sean Whooley talk about the technology and what some of the data has shown so far. TAVR and Critical Care drove Edwards to its fourth-quarter sales beat. Hear more about the overall financial performance and how some of the individual segments performed. Nature Journal is raising questions about Neuralink's BCI study. Whooley explains some of the concerns and why they are important. Medtronic is touting the cost-effectiveness of Linq insertable cardiac monitors. The Fast Five hosts go over what the technology does and what data supported that claim. Insulet has integrated Abbott FreeStyle Libre 2 Plus into the Omnipod 5 technology in Europe. Learn more about the approval and why it's important for Abbott.

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, February 7, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. GE HealthCare posted fourth-quarter results this week that beat estimates on Wall Street. Fast Five hosts Sean Whooley and Danielle Kirsh talk about the financial highlights. A former Tandem chief commercial officer joined Ascensia as president of CGM. Hear who is taking over in this new role and what their responsibilities will be. Dexcom has launched its new ONE+ CGM system in Europe. Whooley explains what the new system is and how it uses some of the company's other technology. The FDA expanded its approval for Boston Scientific's spinal cord stimulation to include chronic back pain without prior back surgery. Learn more about the system and the data that supported the expanded indication.  Philips has a serious BrightView recall due to a potential falling component. The Fast Five hosts talk about the reason behind the recall and if there have been any complaints stemming from the recall. BONUS: Read more from Whooley about Boston Scientific's plan after Farapulse won FDA approval, as well as how catheter design was the key to developing the Farapulse technology.

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, February 6, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Procyrion raised $57.7 million in a Series E funding round for its circulatory support device. Fast Five hosts Danielle Kirsh and Sean Whooley talk about what the funding will support, what its Aortix device is and what executives have to say about the funding raise. Biosense Webster released positive Varipulse pulsed field ablation data. Whooley details which data points stuck out in the InspIRE and AdmIRE studies.  Carthera enrolled its first patients in an ultrasound drug delivery trial. Learn how the ultrasound drug delivery technology works and what the trial will evaluate. 3M could reportedly raise up to $12 billion from its Solventum spinoff. Hear more about what the money raise could be used for and the current status of the spinoff.  LivaNova has picked a longtime J&J executive as its new CEO. The Fast Five hosts share who is joining the company, their career history and the optimism he brings to the company.  BONUS: Read more from Whooley's discussion with ReWalk Robotics' CEO as the company looks ahead following its Lifeward rebrand.

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, February 2, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. BD is increasing its revenue guidance after releasing its Q1 earnings results. Fast Five hosts Sean Whooley and Danielle Kirsh talk about the earnings results and how BD's medical segment performed.  Cortex initiated a trial of its mapping technology for atrial fibrillation ablation. Hear more about the trial and company's technology. SoniVie has completed enrollment in a trial of its ultrasound renal denervation technology for hypertension. Whooley explains how the technology works and how optimistic executives are about completing the trial. Zeiss and Topcon have settled a trade secret theft lawsuit. The Fast Five hosts discuss the terms of the settlement and what Zeiss' original complaint was in the suit. BCI developer Synchron bought an equity stake in thin film maker Acquandas. Find out more about Acquandas' technology and executives' excitement.

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, February 1, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. InspireMD received CE mark approval for its carotid stent system. Fast Five hosts Danielle Kirsh and Sean Whooley discuss how the system works and what executives are saying. BD and Techcyte are collaborating on AI-based cervical cytology. Hear more about the goal of the collaboration and what each company brings to the deal. The FDA has cleared Philips' latest TEE transducer for cardiac care. Whooley talks about the transducer technology and its implications on treatment options for patients. Neuralink this week announced the first-in-human brain-computer interface implants. Learn about the regulatory backing behind the BCI system, how the implant went and some of the recent fire the company has been under. The FDA approved Boston Scientific's Farapulse pulsed field ablation technology this week. The Fast Five hosts talk about what Farapulse does and what's next for the company.

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 31, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Virtual Incision has sent its mini surgical robot to space. Fast Five hosts Danielle Kirsh and Sean Whooley discuss why it sent the robot to space. MagStim won an FDA nod for its latest transcranial magnetic stimulation technology. Learn what the technology is and how it works in today's episode. Abbott entered into a new $5 billion credit facility. Whooley gives the details of the credit facility. The FDA will reassess IceCure Medical's cryoablation technology for destroying tumors. The Fast Five hosts talk about the FDA's decision and what it means for IceCure. BioSig announced layoffs as part of its latest cost-cutting effort. Hear more about the reason behind the layoffs and what executives had to say.

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 30, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. RenovoRX closed a $6.1 million private placement. Fast Five hosts Sean Whooley and Danielle Kirsh discuss what RenovoRX is developing and how it wants to spend the funds.  Vicarious Surgical has picked a former Olympus executive as president. Find out who is taking on this role and some of their career history.  ReWalk Robotics rebranded to 'Lifeward' as its portfolio continues to expand. Whooley shares the reason behind the rebrand and what executives are thinking. Globus Medical is laying off 157 employees at the former NuVasive headquarters. Hear more about the reason behind the layoffs and which departments are affected. Philips has discontinued certain CPAP product lines after the ongoing recall saga. The Fast Five hosts talk about the consent decree and how the company came to this decision. BONUS: Read the top IVD and diabetes stories of 2023.

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 26, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Siemens Healthineers won FDA clearance for its Syngo Virtual Cockpit technology. Fast Five hosts Danielle Kirsh and Sean Whooley talk about what the platform is designed for and how it helps clinicians. CroíValve won an investigational device exemption for its tricuspid heart valve. Learn about some of the features of this heart valve and the optimism executives have going into the trial. Samsung is partnering with Lunit on AI for enhanced chest screenings. Whooley explains the goal of the partnership and what each company brings to it. Boston Scientific launched its VersaVue single-use flexible cystoscope. Hear about what VeraVue is and how it eases workflows for clinicians.  Abbott won an FDA nod for the world's smallest rechargeable DBS system. The Fast Five hosts talk about the DBS system, what makes it unique and what executives are saying.

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 25, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Olympus has completed the acquisition of GI stent maker Taewoong Medical. Fast Five hosts Sean Whooley and Danielle Kirsh go over the details of the deal and what it will add to Olympus' product portfolio. Sight Sciences has closed a $65 million credit facility. Hear the financial details of the credit facility and what executives are saying.  Noah Medical hit the 500-case mark with its Galaxy surgical robot. Whooley gives us a look at what surgeons think about the surgical robot. Abbott posted earnings today that showed double-digit growth across the Medical Devices segment. The Fast Five hosts discuss how it performed financially and how certain segments outperformed others. Intuitive Surgical aims for an FDA clearance for its next-gen Da Vinci 5 surgical robot. Learn about the company's plans to manufacture the system and what details have been provided about the system.

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 24, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Cognito Therapeutics has enrolled its first patients in a sensory neurostim biomarker study. Fast Five hosts Sean Whooley and Danielle Kirsh discuss what the trial will look like and how executives see this transforming treatment option. The UK NHS Trust treated the first patients with Allurion's weight loss balloon. Learn more about the technology and the results from the first treatments. A former Boston Scientific executive joined the board of directors of pulsed field ablation company Mirai Medical. Whooley talks about their career history and what Mirai Medical is doing. Earnings season is upon us, and Johnson & Johnson MedTech has reported a 13% sales uptick in Q4. Hear more updates from the Abiomed acquisition and how the company's electrophysiology portfolio is doing. A new report claims that Samsung is joining Apple in the non-invasive glucose monitor battle. The Fast Five hosts talk about the implications this could have on the glucose monitoring market and if there's a projected timeline. BONUS: How does medtech CEO compensation compare? Read more about the pay dynamics of the medical device industry.

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 23, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. The first international procedures were performed with Activ Surgical's visualization technology. Fast Five hosts Sean Whooley and Danielle Kirsh discuss what the visualization system is and how the company envisions it transforming the operating room. Surmodics has positive early results from its Pounce LP thrombectomy system. Learn what the thrombectomy system does and what doctors think of its performance. The FDA has cleared AI-based lung analysis software from Thirona. Whooley explains what the software does and how it will change personalized treatment. Boston Scientific has positive spinal cord stimulation data. The Fast Five hosts discuss some of the data that stuck out the most and what executives are saying. The FDA has granted breakthrough device designation for Pi-Cardia's leaflet modification device for TAVR. Hear more about the device, what it addresses and the optimism executives have.

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 18, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Clarius won CE mark approval for its handheld full-body ultrasound technology. Fast Five hosts Sean Whooley and Danielle Kirsh discuss how the technology works and how it helps healthcare professionals.  Myomo wants to raise $6 million and has set its sights on Medicare coverage. Hear some of the financial details of the funding raise in today's episode.  FastWave Medical kicked off its first-in-human study of its IVL technology. Whooley explains what the company's IVL technology is and why it is important. The FDA is warning on defective packaging with Exactech's shoulder systems. The Fast Five hosts go over the issue in the warning and what the FDA is recommending.  DermaSensor has received FDA clearance for its AI-powered skin cancer detection device. Learn more about DermaSensor's device and the data that backs it up.

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 17, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. The FDA has cleared ClearPoint Neuro's stereotactic guidance system. Fast Five hosts Sean Whooley and Danielle Kirsh explain what a stereotactic guidance system is and the procedures it can be used in.  Gore enrolled its first patients in an expandable stent graft trial. Hear what the trial will assess and what the expandable stent does.  Fresenius Kabi Has a Class I recall of some Ivenix infusion pumps. Whooley explains the reason behind the recall and what Fresenius Kabi recommends to resolve the issue.  Former Nuvasive CEO Chris Barry has been named president of the 3M HealthCare spinoff's Medical Solutions division. The Fast Five hosts review some recent appointments at 3M and Chris Barry's career history.  Apple is reportedly going to pull pulse oximetry from watches if Masimo's appeal fails. Whooley talks about Apple's workaround, Masimo's reaction and what analysts are saying.

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 12, 2023. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Dental robotics company Neocis raised $20 million for its dental robot. Fast Five hosts Danielle Kirsh and Sean Whooley discuss what the robot does and if its been used in any procedures yet. BrainsWay is initiating a few new studies of non-invasive neurostimulation. Hear what the company wants to assess and how its neurostim system works.  A new study has backed Smith+Nephew's Regeneten bioinductive rotator cuff implant. Whooley explains Regeneten and some of the data points that stuck out.  InBrain Neuroelectronics is leading a project to 'revolutionize' the brain-computer interface landscape. Learn about the company's plans and how it wants to address some of the limitations in BCI.  Nevro this week announced it was laying off 5% of its workforce. The Fast Five hosts talk about how many employees are affected and the reason behind these layoffs.

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 11, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Cala Health recently announced positive essential tremor treatment data. Fast Five hosts Danielle Kirsh and Sean Whooley talk about some of the data points and the optimism executives have.  Hyperfine launched its AI-powered brain imaging technology. Hear how the technology works and what findings hospitals have had using the system. The first arthroplasty cases were performed using Stryker's mixed-reality guidance system. Whooley talks about the features in the system and how it caters to unique patient needs.  3M has won a $34.2 million contract to develop wound care solutions. The Fast Five hosts go over what the award will allow 3M to do and how the company plans to achieve those goals.  Shockwave Medical is planning to grow the company with 2-3 product launches per year. Whooley goes over some of the key points from CEO Doug Godshall's presentation at the J.P. Morgan Conference this week.  BONUS: Whooley shares insights into Dexcom's future glucose sensor developments from his interview with CEO Kevin Sayer.

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.

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 8, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. The FDA cleared Butterfly Network's next-generation handheld ultrasound technology. Fast Five hosts Sean Whooley and Danielle Kirsh take a look at the technology and the recent steps taken by Butterfly Network to continue growing its business. Medtronic won CE mark approval for the MiniMed 780G automated insulin pump with the Simplera Sync disposable, all-in-one CGM. Find out more details on the company's newest CGM technology and how it can benefit people with diabetes in Europe with this approval. Abbott has integrated its FreeStyle Libre 2 Plus into Tandem Diabetes Care's automated insulin pump technology. The hosts break down the latest CGM-insulin pump integration news and look at how this can benefit people with diabetes. LivaNova plans to wind down its advanced circulatory support business unit. The company is the latest to take action to narrow its focus by shifting its organizational structure. Learn more about what this decision entails. Boston Scientific plans to acquire Axonics for $3.7B. One of the busiest companies on the M&A front in medtech has made yet another move, with this one providing a major boost to its Urology portfolio. The Fast Five hosts explain the details of the acquisition and how it folds into Boston Scientific's broader strategy.

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 22, 2023. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Insulet has applauded guidance from NICE on hybrid closed loop insulin delivery systems. Fast Five hosts Sean Whooley and Danielle Kirsh talk about what the guidance recommended and why it is important for Insulet. J&J's Acclarent won an FDA nod for its pediatric ear tube balloon dilation system ahead of its acquisition by Integra Lifesciences. Hear what the balloon dilation system is and what the company designed it for exactly. ResMed is warning on updates to sleep therapy masks with magnets. Learn about the warning, which masks are affected and what it recommends users do. Philips recalled some MRI systems due to the risk of explosion. Whooley shares the issue with the systems and what Philips is doing to rectify the problem. The Securities and Exchange Commission alleged that the former Stimwave CEO defrauded investors out of $41 million with a fake neuromodulation implant. The Fast Five hosts talk about what the SEC is alleging and what the agency is looking for in terms of injunctions.

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 21, 2023. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Pulse Biosciences announced the first human use of its pulsed-field ablation catheter. Fast Five hosts Danielle Kirsh and Sean Whooley discuss how the catheter works and what performing doctors thought about using the device.  Henry Schein is entering the orthopedic extremities market by acquiring a majority interest in TriMed. Whooley talks about how the deal helps Henry Schein and some of the company's other news from this year.  Zoll Medical has disclosed an email phishing attack and potential data breach at the company. Hear what caused the attack and details about whether information as been misused in today's podcast. Philips' BioTelemetry will pay $14.7 million to settle false claims violation allegations, the U.S. Department of Justice has said. The Fast Five hosts go over the allegations and what the DOB contended. Olympus bronchoscopes in a Class I recall could lead to burns and fires. Whooley explains which devices are affected, what could happen with continued use and what the company is recommending.

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 20, 2023. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Merit Medical's founder and CEO announced plans to retire in 2025. Fast Five hosts Sean Whooley and Danielle Kirsh talk succession plans.  Butterfly Network is set to bring ultrasound-on-chip technology to surgical robotics with a new partnership. Hear what its latest partner does and how it will benefit patients.  Ablative Solutions hit its primary endpoint in renal denervation for hypertension in a trial. Whooley talks about the study's results and which data points were important.  Medtronic has a Class I recall for its surgical navigation software. Learn what devices are affected and what the issue is that affects the software.  Illumina is officially divesting Grail following a court decision that backed an FTC ruling. The Fast Five hosts talk about the final decision and how Illumina got to this point.

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 19, 2023. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Luma Vision has raised $22 million for its 4D cardiac imaging and navigation technology. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the technology and what it provides clinicians and cardiologists.  Stryker is set to acquire joint replacement company SERF SAS. Whooley explains what SERF SAS brings to Stryker and Stryker's reasoning behind the deal. Carl Zeiss Meditec made a $1 billion acquisition to enhance its ophthalmic portfolio. Hear about the company it's buying and executives' reactions.  Apple is reportedly stopping sales of some of its Apple Watches in the U.S. amid a patent spat with Masimo. The Fast Five hosts discuss the history of this spay, the turning point and when exactly Apple plans to stop selling those products.  ZimVie is selling its spine business to become a pure-play dental company. Hear more about what the sale is valued at and some of the terms of the purchase agreement.

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 15, 2023. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. HeartBeam this week unveiled an artificial intelligence program for cardiac insights. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the goal of the AI program and HeartBeam's technology that will be used in the program. Microbot Medical and Corewell are collaborating on telerobotics for endovascular surgical robotics. Hear what the goal of the collaboration is and what each company brings to the partnership. The FDA has approved Glaukos' iDose TR glaucoma-treating drug delivery implant. Whooley explains what the approval covers and how the company plans to launch the implant.  J&J's Biosense Webster treated its first patients in the company's dual-energy AFib ablation trial. The Fast Five hosts talk about the technology and some of the other AFib ablation companies in the playing field right now. Medtronic won a landmark FDA approval for its PulseSelect pulsed field ablation. Hear more about the approval, what PulseSelect is and when the company plans to start commercialization.

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 13, 2023. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Cognito Therapeutics reported non-invasive neuromod data for treating Alzheimers this week. Fast Five hosts Danielle Kirsh and Sean Whooley talk about how the company's technology works and some of the data points that stuck out in the report.  Shifamed's Laza Medical closed a $36M Series A funding round to support cardiac imaging technology. Hear what the technology is and what the company hopes to achieve with the imaging technology. Vivasure has treated the first patients with its percutaneous vessel closure device. Learn more about how the device works and what makes it unique in today's episode.  Haemonetics has closed its previously announced acquisition of OpSens. Whooley explains what OpSens brings to Haemonetics and some of the financial details of the deal. ResMed has won a patent spat with NYU. The Fast Five hosts discuss the details of the patent spat and the device behind the legal battle.

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 12, 2023. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. NeuroOne this week received FDA clearance for its neuro ablation technology. Fast Five hosts Sean Whooley and Danielle Kirsh talk about the technology, how it works and what executives think about the opportunities this device could bring to the company.  Medtronic and Cosmo Pharma are expanding their artificial intelligence collaboration for GI Genius. Learn what the goal of the collaboration will be, what GI Genius is and some of the successes Medtronic has seen with GI Genius. CMR Surgical appointed a new chief commercial officer. Hear who takes over and what some of their career history is. BCI maker Synchron has added a former Dexcom CEO to its board of directors. Whooley discusses the appointee's experience and how the diabetes tech experience will benefit Synchron.  AdvaMed picked GE HealthCare CEO Peter Arduini as the new board chair and announced it formed a new medical imaging division. The Fast Five hosts talk about the medical imaging division and what the trade organization sees for the future of that division.

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, Dec. 8, 2023. Check out the show notes at massdevice.com/podcast. Beta Bionics became the second company in as many days to launch an automated insulin pump with the Dexcom G7 CGM. Fast Five hosts Jim Hammerand and Sean Whooley dive into the latest news and break down the key features of the iLet bionic pancreas. Distalmotion selected a former Zimmer Biomet executive to take over as its new CEO. The hosts look into the background of the new figure in the corner office and discuss the Dexter surgical robot platform as the company prepares for its next phase of growth. BD has a new alternative to the traditional venous blood drawing method following FDA clearance for its MiniDraw device. Hammerand and Whooley explain what sets this device apart from other methods and why it could usher in a new era of diagnostics. Medtronic made waves earlier this year when it agreed to acquire insulin patch pump maker EOFlow, but that deal is now off after the medtech giant terminated their acquisition agreement. The hosts discuss the reasons behind Medtronic's decisions and the potential ramifications on the insulin delivery market. Edwards is the latest big-name medtech company to join the spin-off trend, announcing plans to spin its critical care business. Hammerand and Whooley take a look at Edwards' reasoning behind the decision and the areas in which the company now plans to focus once it completes the separation.

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, Dec. 7, 2023. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Merit Medical upsized a private placement to $650 million and could bring in as much as $725 million from the offering. Fast Five hosts Jim Hammerand and Sean Whooley look at the details of the offering, as well as Merit's potential plans with the proceeds. The hosts look at a major reimbursement win for Ambu, breaking down some of the features of the company's single-use bronchoscope technology and why CMS decided to allow incremental reimbursement for outpatient procedures. Levita Magnetics announced the completion of the first procedures outside the U.S. with its surgical robotic technology. Hear all about the magnetic-based MARS platform, the surgeries that took place in South America and what this milestone means to Levita's CEO. Medtronic earned CE mark for the latest device in its Precept family of deep brain stimulation implants. While it remains investigational in the U.S., the hosts look at what this implant brings to the European market as a first-of-its-kind offering. In a milestone announcement for diabetes technology, Tandem Diabetes Care and Dexcom say they launched an integrated artificial pancreas system using Tandem's pump technology and Dexcom's next-generation G7 CGM. Whooley and Hammerand explain the significance of this integration and the benefits for users of the technology.

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.