Medical Devices

  • Close up of a white cylindrical device.
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    Courtesy of Edwards Lifesciences
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    Edwards receives FDA approval for mitral valve replacement system

    The Sapien M3 device is the first approved mitral regurgitation treatment to use a transseptal approach, Edwards said.

    By • Dec. 23, 2025
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    Sarah Silbiger via Getty Images
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    FDA posts Class I recall notice about Medtronic heart vent catheters

    The company received three complaints about patients who had perforation injuries linked to the devices.

    By • Dec. 23, 2025
  • Boston Scientific's Farapulse pulsed field ablation device. Explore the Trendline➔
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    Permission granted by Boston Scientific
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    Trendline

    New medical devices are reshaping the medtech industry

    From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

    By MedTech Dive staff
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    Courtesy of Abbott
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    Abbott receives FDA approval for Volt PFA system

    Abbott can now compete with Medtronic, Boston Scientific and J&J in the U.S. for the fast-growing pulsed field ablation market.

    By • Dec. 22, 2025
  • Modern glass and metal office building with a reflective blue-tinted facade, set against a clear blue sky. In the foreground, a large black and white sign reads “Abbott” with the company’s stylized logo and the number “645.” The area has neatly cut grass and a few small trees.
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    Alamy
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    Abbott receives clearance for heart delivery device in premature babies

    Physician feedback has informed a delivery device designed to make procedures safer and easier.

    By • Dec. 22, 2025
  • A person holds a phone, wearing a white patch on their forearm and an insulin pump on their hip.
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    Courtesy of Medtronic
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    Medtronic’s diabetes spinoff MiniMed files for IPO

    MiniMed is pitching the breadth of its portfolio as an advantage over more focused rivals such as Dexcom and Insulet.

    By • Dec. 22, 2025
  • Blue and yellow flags bearing the European Commission logo fly in front of a building.
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    Carl Court via Getty Images
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    EU proposal would simplify Medical Device Regulation

    If finalized, the changes would reduce the scope of AI regulations for medical devices and include more provisions for rare disease treatments.

    By • Dec. 19, 2025
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    Getty Images
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    Pulse Biosciences wins FDA approval to begin PFA catheter study

    Shorter, nanosecond pulses for treating atrial fibrillation differentiate the company’s approach from existing pulsed field ablation systems on the market.

    By • Dec. 18, 2025
  • CMR Surgical's Versius Plus robotic system is shown in blue lighting.
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    Permission granted by CMR Surgical
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    Robot developers make strides in 2025

    Medtronic and CMR Surgical got the FDA’s green light this month, while SS Innovations applied for clearance. Catch up on the latest in surgical robotics in this coverage roundup.

    By • Dec. 18, 2025
  • Neurosurgeon Vitor Mendes Pereira performs a robotic aneurysm procedure while seated at a console in Panama as other clinicians observe.
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    Permission granted by XCath
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    Profile

    XCath targets better brain aneurysm outcomes with robotic approach

    The Houston-based startup is developing capabilities for endovascular aneurysm repair and stroke treatment that it hopes can bridge a skills gap and get patients treated faster.

    By • Dec. 18, 2025
  • A picture of Moon Surgical's Maestro robotic surgery system.
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    Permission granted by Moon Surgical
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    Moon Surgical adds 5G and Wi-Fi to Maestro robots for cloud-based AI

    The company provided an update on its efforts to win market share, revealing that Maestro has been used to treat over 2,300 patients across all sites of care.

    By • Dec. 18, 2025
  • CMR Surgical's Versius Plus robotic system is shown against a white background.
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    Permission granted by CMR Surgical
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    CMR Surgical gains FDA clearance for new robot

    As competition intensifies among surgical robot makers, CMR said its soft tissue platforms are the second most used systems in the world.

    By • Dec. 17, 2025
  • Professional photo of Josh Makower
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    Permission granted by DaVita
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    Dialysis cannulation can be difficult. A startup is working to improve it.

    X9 is building an ultrasound-guided device used to simplify the process of inserting a needle for cannulation.

    By • Dec. 17, 2025
  • Edwards Lifesciences' Sapien 3 Ultra heart valve replacement system is shown with the valve expanded by a balloon.
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    Courtesy of Edwards Lifesciences
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    CMS considers expanding TAVR coverage to asymptomatic patients

    Medicare reimbursement for aortic stenosis patients without symptoms could accelerate procedure growth for Edwards Lifesciences, which requested the CMS review, analysts said.

    By • Dec. 16, 2025
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    Getty Images
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    FDA gets mixed feedback on performance monitoring for AI

    Medtech industry groups said the FDA should use existing regulatory and quality tools to monitor performance, while medical groups said device manufacturers should be responsible for monitoring AI.

    By • Dec. 16, 2025
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    Courtesy of Philips
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    Philips to acquire SpectraWAVE

    SpectraWAVE makes technologies to help diagnose and guide treatment decisions for coronary artery disease.

    By • Dec. 15, 2025
  • A sign for the FDA is shown in front of the headquarters building in Silver Spring, Maryland.
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    Getty Images
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    FDA needs more staff, authority to oversee device recalls, watchdog finds

    “FDA's challenges — such as insufficient staffing — can create inefficiencies in the process and potentially put lives at risk,” the U.S. Government Accountability Office said.

    By • Dec. 15, 2025
  • AtriCure’s EnCompass Clamp device is shown against a white background.
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    Retrieved from AtriCure on December 12, 2025
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    AtriCure treats first patients with dual PFA/RF system

    Combining pulsed field ablation and a radiofrequency technique in one platform is expected to reduce procedure times.

    By • Dec. 12, 2025
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    Elise Reuter/MedTech Dive, data from MedTech Dive
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    Mick Farrell named chair of AdvaMed board

    The Resmed CEO will serve a two-year term on the medtech lobbying group’s board.

    By • Dec. 12, 2025
  • An anatomical heart is pictured in red in a transparent body.
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    Getty Images
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    Impulse Dynamics raises $158M to commercialize heart failure device

    By strengthening heart contractions, Impulse’s device could improve quality of life, restore functional capacity and enhance tolerance for exercise. 

    By • Dec. 11, 2025
  • A modern office building with large reflective glass windows is shown behind a wide driveway and landscaped entrance. In the foreground, a white and orange monument sign reads "Intuitive Surgical" with the number "1020" vertically on the side.
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    Alamy
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    Intuitive wins 3 new indications for da Vinci SP system

    The robotic surgery market leader’s single port system can now be used in inguinal hernia repair, gallbladder removal and appendectomy procedures.

    By • Dec. 11, 2025
  • A sign for the FDA is shown in front of the headquarters building in Silver Spring, Maryland.
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    Getty Images
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    FDA pilots allowing digital health devices access to CMS payment program

    Companies can ask the FDA to waive premarket authorization and investigational device requirements while they collect real-world data in a CMS program.

    By • Dec. 10, 2025
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    simarik via Getty Images
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    Teleflex inks deals to sell 3 businesses for $2B

    Needham analysts said Teleflex’s inability to secure a price above the low end of their expectations could reflect “the continued poor performance of UroLift.”

    By • Dec. 10, 2025
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    Courtesy of Mayo Clinic
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    GE HealthCare, Mayo Clinic expand partnership around radiology research

    Ben Newton, GE HealthCare’s global head of oncology, said the partnership will shift radiation therapy from a “one-size-fits-all” approach to a personalized method.

    By • Dec. 9, 2025
  • The exterior of Medtronic's Minnesota operational headquarters is shown along with its reflection in a pool of water.
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    Courtesy of Medtronic
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    Medtronic changes investor relations leadership ahead of diabetes spinout

    Ryan Weispfenning has elected to take up the challenge of creating and leading the investor relations function at the planned new diabetes company.

    By • Dec. 9, 2025
  • A person sets a brown, paper bag on a counter and holds another bag. They are wearing a white wristband.
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    Courtesy of Whoop
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    Deep Dive

    What medtech firms can learn from Whoop’s warning letter

    An FDA warning letter about the wearable company’s blood pressure feature raises questions about the blurring lines between medtech and wellness.

    By • Dec. 8, 2025