The Latest

  • Two people view Medtronic's Hugo robotic surgery system in an operating room.
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    Courtesy of Medtronic
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    Deep Dive

    4 medtech topics to watch in 2026

    From insurance coverage questions to M&A and tariffs, here are the top storylines to watch in the medical device space in 2026.

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    Getty Images
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    Teleflex CEO leaving company

    Stuart Randle, who retired in 2018, has replaced Liam Kelly as CEO and president on an interim basis.

  • A nightime shot of the exterior of CMR Surgical's headquarters in Cambridge, U.K., with lights on in the windows of the two-story building.
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    Courtesy of CMR Surgical
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    CMR robot earns CE mark in pediatrics; SS Innovations readies smaller instruments

    CMR Surgical received the approval for abdominal surgery for its Versius platform in patients under age 18 in Europe, while SS Innovations will incorporate five new instruments into its SSi Mantra system.

  • The U.S. capitol building stands in front of a blue sky.
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    Win McNamee via Getty Images
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    House votes to revive enhanced ACA subsidies

    The House voted 230-196 to extend the financial assistance, which lapsed on Dec. 31, for three years. The measure is not expected to pass the Senate.

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    Courtesy of Whoop
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    FDA exempts more wearable, AI features from oversight

    In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical decision support tools that don’t fall under medical device oversight.

  • A sign with company logo in red on a white background at the entrance to Johnson & JOhnson medical device unit
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    Mario Tama/Getty via Getty Images
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    J&J submits FDA de novo request for Ottava robot in general surgery

    Johnson & Johnson’s filing comes a month after Medtronic gained U.S. clearance for its Hugo system as competition in the soft tissue robotic surgery market heats up.

  • Members of a surgical team are shown in the operating room during a robot-assisted surgery in a hospital in Beijing.
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    Courtesy of Surgerii Robotics
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    Surgerii Robotics raises $100M to fund global expansion

    The China-based surgical robot manufacturer is gearing up for growth after receiving Europe’s CE mark last year for its single port endoscopic system.

  • A doctor examines a patient's eyes using a light and a microscope.
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    Getty Images
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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.

  • Stereotaxis' GenesisX surgical robot is shown against a white background.
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    Permission granted by Stereotaxis
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    Stereotaxis wins FDA approval for robotically navigated ablation catheter

    Stereotaxis’ CEO said the company has been “hampered clinically, commercially and strategically” by its prior dependence on a J&J catheter.

  • Professional photo of Ricky Bloomfield
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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.

  • A 3D visualization of red blood cells traveling through a blood vessel.
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    Getty Images
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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.

  • 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.

  • 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.

  • 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.

  • The facade of the U.S. Capitol building is seen along with trees and a reflection pond
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    Kara Arundel/MedTech Dive
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    Time’s up: Enhanced ACA subsidies expire

    The expanded tax credits are officially dead after lawmakers failed to secure an extension before the end-of-year deadline. There’s still a chance, though a small one, that they could come back in 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.

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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.

  • 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.

  • 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.

  • 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.

  • Doctor, team and tablet in discussion with senior for healthcare training, advise or support at hospital.
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    stock.adobe.com/Kay A/peopleimages.com

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    HHS seeks input on speeding AI adoption in clinical care

    The request for information comes as the Trump administration has largely taken a deregulatory stance on AI, in a bid to avoid hampering the technology’s rollout.

    AI
  • 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.

  • 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.

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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.

  • 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.