Medical Devices: Page

  • Photo of Michael F. Mahoney, CEO of Boston Scientific.
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    Courtesy of Boston Scientific
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    Boston Scientific to acquire Penumbra for $14.5B

    With the planned purchase, Boston Scientific will gain several thrombectomy devices to remove clots from blood vessels.

    By • Jan. 15, 2026
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    Courtesy of Precision Neuroscience
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    Medtronic inks deal to build brain computer interface into surgical system

    Medtronic will integrate Precision Neuroscience’s Layer 7 cortical interface with its StealthStation surgical navigation system.

    By • Jan. 15, 2026
  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. Explore the Trendline➔
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    Sarah Silbiger via Getty Images
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    Trendline

    Top 5 stories from MedTech Dive

    From the effects of layoffs at the Food and Drug Administration and President Donald Trump’s tariff policies to the top medtech trends of 2026, here is a collection of top stories from MedTech Dive.

    By MedTech Dive staff
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    Elise Reuter/MedTech Dive
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    Deep Dive

    5 topics to watch as MDUFA negotiations restart

    The next Medical Device User Fee Amendments, which will set how much the FDA can raise from the industry in fees over a five-year period, are expected to go to Congress this year.

    By • Jan. 14, 2026
  • Boston Scientific's Farapoint pulsed field ablation catheter is shown against a white background.
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    Permission granted by Boston Scientific
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    Boston Scientific gains FDA’s OK for new PFA catheter

    The Farapoint device adds another tool to the company’s pulsed field ablation portfolio that could help increase or sustain its electrophysiology market share, one analyst said.

    By • Jan. 14, 2026
  • Three stacked wooden cubes on the right side of the frame read "M&A"
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    Getty Images
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    Smith & Nephew to acquire Integrity Orthopaedics for up to $450M

    The company has committed the cash, half of which it is paying upfront, to buy Integrity Orthopaedics for its rotator cuff repair system.

    By • Jan. 14, 2026
  • 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.
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    Permission granted by Medtronic
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    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.
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    Courtesy of Inspire Medical Systems
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    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 headquarters building is shown.
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    Courtesy of Boston Scientific
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    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.
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    Courtesy of Edwards Lifesciences
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    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.
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    Permission granted by Haemonetics
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    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.
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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.

    By • Jan. 9, 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.

    By • Jan. 9, 2026
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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.

    By • Jan. 8, 2026
  • 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.

    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.
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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.

    By • Jan. 7, 2026
  • 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.

    By • Jan. 7, 2026
  • 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.

    By • Jan. 7, 2026
  • 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.

    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
  • 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.

    By • Jan. 6, 2026
  • 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.

    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