Medical Devices: Page 9

  • A person sits on a ledge with their legs in the water and eats. A patch is on their arm and a pen is on the ground next to food.
    Image attribution tooltip
    Permission granted by Medtronic
    Image attribution tooltip

    Medtronic gets FDA clearance for smart insulin pen app

    The app pairs Medtronic’s smart insulin pens with a sensor made by Abbott.

    By • Jan. 13, 2026
  • A picture of Inspire Medical Systems' patient app and remote.
    Image attribution tooltip
    Courtesy of Inspire Medical Systems
    Image attribution tooltip

    Inspire appoints Matt Osberg as CFO

    While Osberg joins Inspire without prior medtech experience, CEO Tim Herbert says the new CFO can help take the company “to the next level.”

    By • Jan. 13, 2026
  • Boston Scientific's Farapulse pulsed field ablation device. Explore the Trendline➔
    Image attribution tooltip
    Permission granted by Boston Scientific
    Image attribution tooltip
    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
  • Boston Scientific's headquarters building is shown.
    Image attribution tooltip
    Courtesy of Boston Scientific
    Image attribution tooltip

    Boston Scientific to buy incontinence device maker Valencia

    The deal would set up Boston Scientific to compete with Medtronic in the market for neuromodulation devices that work by stimulating the tibial nerve.

    By • Jan. 12, 2026
  • A corporate building for Edwards Lifesciences.
    Image attribution tooltip
    Courtesy of Edwards Lifesciences
    Image attribution tooltip

    Edwards calls off JenaValve buyout after court halts deal

    Edwards terminated the deal after the Federal Trade Commission moved to block the acquisition due to anticompetitive concerns.

    By • Jan. 12, 2026
  • An image of a medical device with a white and blue handle, a metal rod and a circular tip.
    Image attribution tooltip
    Permission granted by Haemonetics
    Image attribution tooltip

    Haemonetics to acquire Vivasure Medical

    The purchase is expected to expand Haemonetics’ impact in fast-growing markets for structural heart and endovascular procedures.

    By • Jan. 9, 2026
  • 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.
    Image attribution tooltip
    Courtesy of CMR Surgical
    Image attribution tooltip

    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.

    By • Jan. 9, 2026
  • A person walks toward a door while carrying a briefcase.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Teleflex CEO leaving company

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

    By • Jan. 9, 2026
  • A person hits a soccer ball with their head while wearing a wristband.
    Image attribution tooltip
    Courtesy of Whoop
    Image attribution tooltip

    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.

    By • Jan. 8, 2026
  • Two people view Medtronic's Hugo robotic surgery system in an operating room.
    Image attribution tooltip
    Courtesy of Medtronic
    Image attribution tooltip
    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.

    By • Jan. 8, 2026
  • Members of a surgical team are shown in the operating room during a robot-assisted surgery in a hospital in Beijing.
    Image attribution tooltip
    Courtesy of Surgerii Robotics
    Image attribution tooltip

    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.

    By • Jan. 7, 2026
  • A sign with company logo in red on a white background at the entrance to Johnson & JOhnson medical device unit
    Image attribution tooltip
    Mario Tama/Getty via Getty Images
    Image attribution tooltip

    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.

    By • Jan. 7, 2026
  • Stereotaxis' GenesisX surgical robot is shown against a white background.
    Image attribution tooltip
    Permission granted by Stereotaxis
    Image attribution tooltip

    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.

    By • Jan. 7, 2026
  • A doctor examines a patient's eyes using a light and a microscope.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Courtesy of Vicarious Surgical
    Image attribution tooltip

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

    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
  • Professional photo of Ricky Bloomfield
    Image attribution tooltip
    Permission granted by Oura
    Image attribution tooltip
    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
  • A brick building with a sign that says "Henry Schein Inc."
    Image attribution tooltip
    Bruce Bennett via Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Courtesy of Edwards Lifesciences
    Image attribution tooltip

    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
  • FDA
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Courtesy of Abbott
    Image attribution tooltip

    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.
    Image attribution tooltip
    Alamy
    Image attribution tooltip

    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.
    Image attribution tooltip
    Courtesy of Medtronic
    Image attribution tooltip

    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.
    Image attribution tooltip
    Carl Court via Getty Images
    Image attribution tooltip

    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
  • FDA sign
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Permission granted by CMR Surgical
    Image attribution tooltip

    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