Medical Devices

  • A doctor examines a patient's eyes using a light and a microscope.
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    STAAR shareholders reject Alcon’s revised buyout offer

    The implantable lens maker said it would remain a stand-alone company after its shareholders turned down Alcon’s $1.6 billion offer.

    By • Jan. 6, 2026
  • Vicarious Surgical's robotic system.
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    Courtesy of Vicarious Surgical
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    Vicarious inks software partnership as it streamlines operations

    Under the agreement, the engineering partner will be responsible for a significant portion of the software development for the Vicarious robotic system.

    By • Jan. 6, 2026
  • 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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    Biobeat raises $50M to commercialize cuffless blood pressure monitor

    The company will use the money to try to establish its cuffless device as a go-to option for 24-hour blood pressure monitoring in the U.S.

    By • Jan. 6, 2026
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    Permission granted by Oura
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    Q&A

    Ōura’s Ricky Bloomfield proposes new regulatory pathway for wearable health features

    The chief medical officer is interested in an easier path to market for health screening features in wearable devices.

    By • Jan. 5, 2026
  • The SS Innovations SSi Mantra robotic system.
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    Permission granted by SS Innovations
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    Meet 5 medtech companies redefining surgical robotics

    Executives at companies innovating a range of new robotic surgery platforms shared their progress and challenges in MedTech Dive's series of profiles.

    By • Jan. 5, 2026
  • A brick building with a sign that says "Henry Schein Inc."
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    Bruce Bennett via Getty Images
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    New Henry Schein CEO expected by mid-January as Bergman extends tenure

    Stanley Bergman has worked at Henry Schein for 45 years, more than 35 of which he spent as CEO, and was due to retire at the end of 2025.

    By • Jan. 5, 2026
  • 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
  • A picture of a medical catheter against a white background.
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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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    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
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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
  • A person sits in a white chair and looks to the side.
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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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    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