DeviceTalks Podcast Network

Kevin Hykes, CEO of Augmedics, discusses his journey in the Medtech industry and the development of their augmented reality surgical navigation system, xvision, which allows surgeons to project a image onto a headset display, eliminating the need to look away from the surgical field. The system has been shown to improve accuracy, reduce radiation, and facilitate minimally invasive approaches to spine surgery. Augmedics recently raised $82.8 million in a Series C financing round, which will be used to further develop the technology and expand their commercial footprint. Hykes also shares takeaways and lessons from his past stints as a medtech CEO, including great advice for people looking for their first opportunity. "You need to do it for the right reasons, which I think are the thrill of the chase, the fast pace, the shortened cycle times, the chance to be in the cutting edges of technology in our field."

In our newsmaker section, Associate Editor Sean Whooley joins co-hosts Tom Salemi and Chris Newmarker with his report form the American Diabetes Association annual meeting. He shared news from Dexcom, Medtronic, Insulet, Senseonics, Novo Nordisk, Abbott, Fractyl Labs and others.

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In this episode of DeviceTalks Weekly we’ll talk with Mike Favet, CEO of NeuroPace, about how the company’s RNS technology is helping to transform the lives of patients with drug-resistant epilepsy. NeuroPace, one of the pioneers in neurostimulation, has the only FDA-approved neurostim treatment for epilepsy. Favet took over as CEO four years ago from the founding CEO so we discuss his background, the changes he made at the company, and how NeuroPace is building a market for a medical device to treat a disease that typically can be managed only by pharmaceuticals.

Mike Favet will be a panelist on a keynote panel about building a neuromodulation market at DeviceTalks West on Oct. 18-19 at the Santa Clara Convention Center.

Co-hosts Tom Salemi and Chris Newmarker introduce a new formula for the Newmarker’s Newsmaker. Companies mentioned including Philips, Biotronik, Medtronic, Johnson & Johnson, GE Healthcare, Depuy Synthes, BD, and many others.

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In the opening episode of the DeviceTalks podcast network's newest podcast, AbbottTalks, Dr. Christopher Piorkowski, Divisional VP and Chief Medical Officer of Electrophysiology, and Dr. Philip Adamson, Divisional VP and Chief Medical Officer of Heart Failure, discuss the significant advancements in Abbott's cardiac technology and their forward-looking approach to cardiovascular care.

Piorkowski sheds light on the profound impact of technology on patient outcomes in AFib treatment and underscores the importance of enhanced risk stratification tools and personalized therapy approaches. Adamson delves into the progress of Abbott's HeartMate series, specifically the HeartMate 3, highlighting its improved performance and reduced complications compared to its predecessors. Both Abbott leaders stress the essential role of implementation science and foresee an upward trend in enhanced patient identification to administer therapies like the HeartMate 3, aiming to reach patients across the disease spectrum who could significantly benefit from these advanced therapies.

Listen now to AbbottTalks' first episode, and make sure to subscribe on all major podcast platforms to get the behind-the-scenes look at Abbott's transformative work across its diverse portfolio.

This episode is sponsored by Coatings2Go. For more information go to Coatings2Go.com.

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Ariel Sutton, general manager of Imperative Care’s stroke business, joins us to explain why she swapped her medical school dreams for the opportunity to wear steel-toed boots and a hard hat as an engineer. Sutton ultimately would marry her love of medicine with her passion for engineering and built a career helping medical device companies of many sizes to build successful programs. Now she’s leading one of the fastest growing neurovascular businesses in the industry. In her new role she’s going to help guide Imperative Care’s plans to target stroke from many different directions, including surgical robotics. Learn more about Imperative Care here. https://imperativecare.com/zoom-stroke-solution/

This week’s episode is sponsored by DeviceTalks West. Registration opens later next week. Go to DeviceTalks.com.

Co-hosts Chris Newmarker and Tom Salemi review this week’s Newmarker’s Newsmakers including iRhythm, Medtronic, Illumina, Hologic, Senseonics, and Know Labs.

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In this episode of Boston Scientific Talks, Peter Pattison, President, Interventional Oncology, and Liza Davis, VP of R&D, Interventional Oncology, share insights into the acquisition of Obsidio and the integration of its unique gel embolic material technology into Boston Scientific's portfolio.

The technology, described as a "conformable solid," offers a unique balance between a liquid and solid embolic, providing physicians with precise control and rapid occlusion during interventional oncology procedures. The discussion also covers the successful transition from FDA approval to commercialization, with Obsidio technology already being used in several cases. Looking ahead, Pattison and Davis discuss the potential for further applications of the technology and its integration with Boston Scientific's new coil products.

This episode is sponsored by the Medical Business Unit at TE Connectivity. For more information go to TE.com/medical.

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In this episode of IntuitiveTalks, David Robinson, VP of Multiport Design Engineering at Intuitive, delves into the intricacies of the company's multiport system, a flagship product that has been continuously refined since its inception.

Robinson discusses the development of the surgical stapler and the surgical table, two key system components, and highlights the unique challenges faced in designing a robotic surgical stapler and ensuring the surgical table could move in sync with the robotic arms for precise operations.

The episode also explores the evolution of the multiport system and how additions like the stapler, vessel sealer, and table motion capability have significantly enhanced the system's functionality.

Finally, Robinson underscores the importance of critical feedback from surgeons in driving these improvements and shares his excitement about the future of Intuitive Surgical and the impact of their work on improving patient care. Tune into this episode for a fascinating look into the world of robotic-assisted surgery and the ongoing efforts to enhance surgical precision and patient outcomes.

Join us and hundreds of other medtech insiders at DeviceTalks West, October 18-19 in Santa Clara, Ca. Find out more at west.devicetalks.com.

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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.

The partnership between HeartBeam and Samsung is a significant development in the field of cardiac care, as it combines HeartBeam’s expertise in cardiac services with Samsung’s global reach and technological prowess. Fast Five hosts Danielle Kirsh and Chris Newmarker have all the details of the partnership.

Concept Medical’s FDA IDE approval for the sirolimus-coated balloon MagicTouch PTA is a significant development in the treatment of superficial femoral artery disease. This approval allows for the investigation of the device’s safety and efficacy in treating this condition. Kirsh and Newmarker discuss the approval and the other indications the device has received in recent months.

Think Surgical’s FDA clearance of its handheld robotic knee surgery device, the TMINI miniature robotic system, represents a major milestone in the field of orthopedic surgery. This innovative technology assists surgeons in performing total knee surgeries with enhanced precision and control. Newmarker explains how the technology works and how it compares to other surgical robots on the market.

The transition of Medtronic’s Cardiovascular Diagnostics and Services President Julie Brewer to Baxter highlights the mobility and talent exchange within the medical device industry. Kirsh and Newmarker talk about the shuffle amidst a time of layoffs.

Titan Medical’s decision to license out all of its intellectual property to Intuitive Surgical signifies a strategic shift in the company’s focus. In a push to further reduce operating costs in the business, Titan Medical also announced some executive changes, including the resignation of its CEO. Newmarker shares all the details of the licensing deal and who’s moving on in the executive suite.

In this episode, Cheryl R. Blanchard, Ph.D., CEO of Anika Therapeutics, explains how the company is morphing from a biomaterials into a joint preservation business. In an interview with Tom Salemi, editorial director of DeviceTalks, Blanchard points to collaboration she had with biomedical greats over her career, including a formative connection with Ray Elliott, the former CEO of Zimmer. Today, through sizable M&A and internal development, Anika is building a portfolio of ortho biomaterials and new joints that gives is more shots on net. Blanchard explains how Anika’s opportunity has grown its market opportunity from $1 billion to $8 billion.

Chris Newmarker, executive editor of life sciences, brings this week’s Newmarker’s Newsmakers bringing news from Neuralink, Abbott, Cala Health, Cue Health, Medtronic, and Zoll Medical.

Senior Editor Danielle Kirsh also visits to introduce DeviceTalks Weekly listeners to the new Fast Five Podcast, a daily podcast highlighting the biggest news in medtech. You can subscribe to the MassDevice Fast Five on any major podcast application.

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