The Latest

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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.

  Medical Devices

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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

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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.

  Digital Health

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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. 

  Medical Devices

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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.

  Medical Devices

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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.

  Medical Devices

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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.

  Medical Devices

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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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  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.

  Digital Health

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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.

  Medical Devices

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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.

  Medical Devices

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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.

  Digital Health

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  ECRI names misuse of AI chatbots as top health tech hazard for 2026

  The nonprofit said technologies like ChatGPT have suggested incorrect diagnoses, invented body parts and otherwise provided information that could lead to harm.

  Digital Health

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  J&J’s cardiovascular business boosts medtech growth in 2025

  Cardiovascular was the only business unit to grow by double digits last year, helping to fuel the overall medical device business to top $33 billion.

  Medical Devices

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  Medtronic to buy up to $90M stake in heart valve developer Anteris

  Medtronic’s investment is contingent on Anteris completing a proposed $200 million public stock offering.

  Medical Devices

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  BVI appoints Jim Hollingshead as CEO

  Hollingshead, the former CEO of Insulet, will lead BVI as it uses a $1 billion financing to support its global eye care business.

  Medical Devices

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  3 takeaways from Boston Scientific’s $14.5B Penumbra deal

  Penumbra is expected to give Boston Scientific more of a presence in the vascular surgery market, with little overlap between the two companies’ products.

  Medical Devices

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  Abbott gets Europe’s CE mark for dual ablation catheter

  The device can deliver both radiofrequency energy and pulsed field ablation to treat heart arrhythmias.

  Medical Devices

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  Boston Scientific recalls stent over issue linked to 3 deaths

  The company said the deaths were associated with off-label or investigational use of the device.

  Medical Devices

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  Intuitive says general surgery, acute care fuel US robot momentum

  CEO Dave Rosa said a strong rollout for the da Vinci 5 surgical robot in 2025 exceeded expectations, with the system driving greater utilization than the earlier Xi model.

  Medical Devices

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  STAAR CEO exits after company rejects Alcon buyout

  An activist investor has reshaped the board, securing the departures of STAAR’s CEO and chair.

  Medical Devices

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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.

  Medical Devices

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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.

  Medical Devices

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  Trump unveils healthcare affordability plan

  The “Great Healthcare Plan” is vague, but would send money directly to ACA enrollees and entrench Trump’s drug pricing deals.

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  Trump issues 25% tariffs on narrow range of semiconductors

  The levies, effective Jan. 15, do not cover products used for data centers and consumer applications, per a proclamation signed Wednesday.

  Medical Devices

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