The Latest

  • A person sits on a couch with a white patch on their upper arm and a rectangular device with a screen on their hip.
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    Courtesy of Beta Bionics
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    Beta Bionics receives FDA warning letter

    The letter, which the FDA has not yet published, does not affect Beta Bionics’ ability to market, manufacture or distribute products, the company said.

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    STAAR names interim co-CEOs amid search for permanent leader

    The company is looking for a new top executive after former CEO Stephen Farrell left when STAAR shareholders rejected a buyout offer from Alcon.

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    Chip Somodevilla via Getty Images
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    Lawsuit challenges ethylene oxide exemptions for device sterilizers

    The lawsuit questions the Trump administration’s authority to make sweeping environmental exemptions without evidence.

  • A Grail employee in a white coat works in a lab.
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    Courtesy of Grail
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    Grail files for FDA approval of multi-cancer early detection test

    Premarket approval could help the company secure coverage from commercial payers and Medicare.

    FDA
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    Joe Raedle via Getty Images
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    ACA enrollment backslides to 23M in 2026

    That’s down 5% from last year. But it’s not the nosedive some market watchers predicted, and a handful of states — notably, Texas — saw robust growth.

  • Aerial view of a sprawling Boston Scientific manufacturing plant
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    Courtesy of Boston Scientific
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    Top medtech trends to watch in 2026

    From M&A to surgical robotics and user fee negotiations, the medical device industry has a busy year ahead. Check out MedTech Dive’s roundup of the top medtech trends to watch in 2026.

  • Four robots side by side with a single arm have different instruments attached to the end.
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    Courtesy of Stryker
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    Stryker starts first cases with handheld ortho robot

    Stryker expects the robot, called Mako RPS, to bring in new customers, including more ambulatory surgery centers.

  • A black reader is shown on top of a phone with a blood glucose reading.
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    Permission granted by Senseonics
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    Senseonics wins CE mark for one-year CGM

    The company is hiring sales reps and transitioning staff from its former partner to support launches in Germany, Italy, Spain and Sweden.

  • Three clinicians work with a robotic surgery system as a patient lies on the operating table.
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    Permission granted by Medtronic
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    Deep Dive

    5 robotic surgery trends to watch in 2026

    Soft tissue robotic systems designed to improve surgical precision are expanding into new specialties and increasing competition for longtime industry leader Intuitive Surgical.

  • A modern architectural design building featuring a red-brick façade with large glass windows displays a prominent sign of the Food and Drug Administration.
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    Alamy
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    CDRH on track for review timelines despite staff cuts

    The Center for Devices and Radiological Health said it is on track to meet review times specified by user fee agreements, despite “resource challenges.”

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    Getty Images
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    Top medtech conferences in 2026

    The medical device industry has a jam-packed year of events for professionals to attend, including the J.P. Morgan Healthcare Conference, DeviceTalks Boston and AdvaMed’s annual medtech meeting.

    Updated Jan. 28, 2026
  • Michael Iskra, wearing a navy blue jacket and light blue shirt, smiles in a head shot.
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    Permission granted by Cleveland Diagnostics
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    Cleveland Diagnostics names Michael Iskra CEO

    Iskra will help Cleveland Diagnostics scale up commercial adoption of its IsoPSA blood-based test that analyzes the structure of protein biomarkers for prostate cancer signals.

  • 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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    Medtech M&A took off in the second half of 2025: report

    Acquisitions and spinoffs in 2025 surpassed the previous three years, according to a report from Bain & Company.

  • 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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    Edwards’ request for broader TAVR Medicare coverage gets pushback

    Several medical societies supported extending Medicare coverage for TAVR to patients with asymptomatic aortic stenosis, but some physicians and rival Medtronic said more data is needed.

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    Permission granted by Becton Dickinson
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    BD, Waters set completion date for $17.5B biosciences and diagnostics merger

    With Waters stockholders voting to issue shares, the companies are targeting a Feb. 9 close date for the deal.

    M&A
  • A picture of five Ōura smart rings against a gold background.
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    Courtesy of Ōura
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    FDA guidance eases wearables oversight. But experts have questions about what’s next.

    Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will navigate a growing pool of wearables.

  • Surgeon and Nurses at Surgery Room
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    Getty Images
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    Medtronic targets ASCs with extended Mindray collaboration

    Mindray is integrating Medtronic patient monitoring technologies into its platforms to meet the needs of ambulatory surgery centers. 

  • Two clinicians wearing scrubs stand in front of Intuitive Surgical's da Vinci 5 robotic surgery system.
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    Courtesy of Tampa General Hospital
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    Intuitive’s cardiac initiative includes valve repair, LAA closure

    With nine new procedures cleared for the da Vinci 5 robot, Intuitive’s strategy includes working with a limited number of U.S. sites this year to establish cardiac programs.

  • The exterior of Medtronic's Minnesota operational headquarters is shown along with its reflection in a pool of water.
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    Courtesy of Medtronic
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    Medtronic wins CE mark for single-shot pulsed field ablation catheter

    Medtronic’s Affera Sphere-360 is a single-shot device, putting it in direct competition with Boston Scientific’s Farawave catheter.

  • A surgeon sits at the console of a da Vinci 5 robot while another medical professional works in the background.
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    Courtesy of Intuitive Surgical
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    Intuitive pushes into cardiac robotic surgery, ASCs

    The robotics giant revealed on an earnings call that it won FDA clearance for several cardiac procedures and is also ramping up its presence in ambulatory surgery centers.

  • The top of the U.S. Capitol Building's dome is pictured on a cloudy day.
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    Win McNamee via Getty Images
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    Congress eyes tackling healthcare consolidation

    “I think there’s common ground here,” one Republican congressman said Wednesday during a House Budget Committee hearing. Squaring up against healthcare monopolies would be a major pivot for the GOP.

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    Elise Reuter/MedTech Dive, data from MedTech Dive
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    AdvaMed leaders on tariffs, MDUFA and wearables

    AdvaMed CEO Scott Whitaker and Mick Farrell, new board chair of the trade group, weighed in on important issues for the medtech industry one year into the Trump administration.

  • A modern architectural design building featuring a red-brick façade with large glass windows displays a prominent sign of the Food and Drug Administration.
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    Alamy
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    Integra recalls wound and burn devices amid reports of serious injuries

    Packaging failures could lead to breaches in the sterile barrier and patient infections.

  • 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 posts Q4 sales below expectations

    Pricing challenges in Abbott’s nutrition business and lower than expected sales of continuous glucose monitors drove down the company’s shares.

  • A hand holding a smartphone displaying Amazon's Health AI assistant.
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    Courtesy of Amazon
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    Amazon launches health AI chatbot for One Medical members

    The assistant, which can answer health questions and help schedule appointments, comes on the heels of other health-focused AI tools from OpenAI and Anthropic.