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. Thanks for listening to the DeviceTalks Weekly Podcast. Subscribe to the DeviceTalks Podcast Network to receive future episodes of this podcast as well as Boston Scientific Talks, IntuitiveTalks, and StrykerTalks.

This episode of DeviceTalks Weekly brings you DeviceTalks Boston’s opening keynote conversation with Tom Polen, CEO, President and Chairman of Becton Dickinson. In the conversation, Polen recounts his tragic first encounter with the medical device industry, his path into medtech and the CEO’s chair, and the work BD put into helping the world survive the COVID-19 pandemic while also repositioning the company with key M&A and divestitures. The episode was sponsored by Clari. Go to Clari.com to learn about its unique revenue management platform. Chris Newmarker also delivers his Newmarker’s Newsmakers featuring news from Siemens Healthineers, Abbott, Intuitive, Cook Medical, Shockwave Medical, Medtronic and Johnson & Johnson. Thanks for listening to this episode of the DeviceTalks Weekly Podcast. Subscribe to the DeviceTalks Podcast Network on any major podcast application.

In this compelling episode of Boston Scientific Talks, Kathryn Unger, VP of ESG, and Brad Sorenson, EVP of Global Operations, delve into Boston Scientific's transformative Environmental, Social, and Governance (ESG) initiatives, exploring how these principles are influencing supplier relationships, impacting product design, and exceeding customer expectations. Additionally, they discuss strategies to align business operations with ESG objectives to foster employee engagement, improve patient outcomes, and better support communities. Tune in to this episode for a comprehensive understanding of Boston Scientific's commitment to balancing quality, environmental sustainability, and social responsibility in the medical device industry. Thank you to Canon Virginia for sponsoring this episode. To learn more about how Canon Virginia works with medical device companies, visit www.cvi.canon.com/ Thank you for listening to the Boston Scientific Podcast. Subscribe to this podcast on every major podcast platform.

In our closing session of DeviceTalks Boston, Chris Newmarker, executive editor of life sciences, and Tom Salemi, Editorial Director of DeviceTalks, sit down with two leaders in the field to break down the event and highlight some of the changes coming Medtech’s ways. Joe Mullings, CEO of the Mullings Group, and former J&J Medtech leader Peter Stebbins, now executive chairman of Nurami Medical, cover a broad range of topics on how will Big Pharma, AI, data, private equity and other external forces will impact the medical device industry. Are we going to see more roll ups from PE? Will a new threat emerge to thwart Medtech’s connected care plan. Also, what were the takeaways from the discussions of the conference. Give a listen. Thanks to everyone who made DeviceTalks Boston so special! Thanks for listening to the DeviceTalks Weekly podcast. Subscribe on any podcast application.

Last call for DeviceTalks Boston! In this episode we'll preview our upcoming conference by talking with Paul Grand, CEO of Medtech Innovator, Rebecca Whitney, SVP at ZimView, Holly Scott and Joe Mullings at the Mullings Group. We'll have Fastball Pitches from two Medtech Innovator companies that will be presenting on May 10-11. Register at DeviceTalks.com. Use the code DTWeekly25 to save 25% Chris Newmarker delivers his #newmarkernewsmakers featuring 3M, Zimmer Biomet, Stryker, Medtronic and Casana, maker of a now FDA-approved smart toilet seat. Thanks for listening to the DeviceTalks Weekly Podcast. Subscribe to the DeviceTalks Podcast Player on any major podcast application.

In this episode of Boston Scientific Talks, Boston Scientific's Cat Jennings, President of Peripheral Vascular, and Dave Knapp, VP of R&D, discuss how they are working together to develop new products and technologies that will help patients with peripheral vascular disease, and how they are leveraging data and analytics to drive innovation. They also share their perspectives on the challenges and opportunities in the medical device industry, the importance of diversity and inclusion in the workplace, and how Boston Scientific is positioning itself for future growth. Tune in to this episode to learn more about how the company is adapting to meet the changing needs of the healthcare industry. Thank you to Resonetics for sponsoring this episode. Go to Resonetics.com for more information about the company. Thank you for listening to the Boston Scientific Podcast. Subscribe to this podcast on every major podcast platform.

In this episode, Tom Salemi interviews Mark Dickinson, worldwide president at Cerenovus, the neurovascular business at Johnson & Johnson Medtech. Mark Dickinson shares his unique entry into the medical device industry, how he built his career at the global company, and what the company is doing to develop its devices to treat stroke patients. In addition, we’ll also have interviews with Paul Grand, CEO of Medtech Innovator, and Jeff Alvarez, chief strategy officer at Moon Surgical. Both will be speaking at DeviceTalks Boston on May 10-11. Go to DeviceTalks.com to register. This episode is sponsored by the Medical Business Unit at TE Connectivity. For more information go to TE.Com/medical. Thanks for listening to this episode of the DeviceTalks Weekly Podcast. You can subscribe to the DeviceTalks Podcast Network on any major podcast application.