The Latest

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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.

  Medical Devices

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  Illumina names former NIH genomics director as chief medical officer

  The company unveiled the appointment alongside news of the departure of its chief commercial officer.

  Diagnostics

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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.

  Medical Devices

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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.

  Medical Devices

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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.

  Medical Devices

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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.

  Medical Devices

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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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  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.

  Digital Health

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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.

  Medical Devices

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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.

  Medical Devices

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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.

  Medical Devices

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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.

  Medical Devices

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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.

  Digital Health

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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.

  Medical Devices

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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.

  Medical Devices

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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.

  Medical Devices

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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.

  Medical Devices

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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.

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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.

  Medical Devices

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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.

  Medical Devices

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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.

  Medical Devices

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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.

  Medical Devices

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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.

  Medical Devices

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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

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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.

  Medical Devices

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