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  • 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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    FDA seeks feedback on monitoring real-world performance of AI devices

    The agency is looking for ways to detect, assess and mitigate changes to the performance of AI-enabled devices over time.

  • A rendering of a rounded device with a wire structure surrounded by mesh.
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    Courtesy of Boston Scientific
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    Boston Scientific unveils plans for new Watchman device

    The company hopes to launch its next-generation Watchman system in the second half of 2027 or early 2028.

    Updated Oct. 14, 2025
  • A modern industrial building with beige and white walls and large blue-tinted glass windows. The name “Stryker” is mounted in black letters on the upper portion of the building. A white smokestack protrudes from the roof, and the sky is light and partly cloudy.
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    Alamy
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    Medtech firms splitting into ‘haves’ and ‘have-nots’: EY

    The number of medtech funding rounds has declined in recent months, but the value of overall deals has increased, according to a new report from EY.

  • The HHS in DC
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    Getty Images
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    HHS plans to furlough more than 40% of staff if government shuts down

    Under the contingency plan, the CMS would lose 47% of its staff, while the CDC and the NIH would lose 64% and 75%, respectively.

    FDA
  • FDA headquarters sign
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    Getty Images
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    FDA expands early alert program to cover all medical devices

    After a successful pilot, the agency has lifted the limitations on when it will provide early information about potentially high-risk safety events.

  • Letters appear clearer in an eye chart on a yellow wall viewed through glasses.
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    Getty Images
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    EssilorLuxottica wins FDA OK for myopia-slowing eyeglass lenses

    Investigators saw a 71% reduction in myopia progression in children who used the lenses for two years.

  • EU flags in front of the Berlaymont building, headquarters of the European Commission in Brussels, Belgium.
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    Getty Images
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    MedTech Europe pressures EU to make regulatory changes by early 2026

    The request includes a call to postpone re-certification requirements for devices already certified under the medical technology regulations.

  • The SS Innovations SSi Mantra robot's five modular arms and surgeon console are shown.
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    Permission granted by SS Innovations
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    SS Innovations hires new CFO

    Naveen Kumar Amar joins the surgical robot developer as it prepares to expand globally, including in Europe and the U.S.

  • A person wears a small, white round sensor on their forearm.
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    Courtesy of Biolinq
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    Biolinq gets FDA de novo nod for intradermal glucose sensor

    The device, called Biolinq Shine, is indicated for people with Type 2 diabetes who don’t depend on insulin.

    Updated Sept. 29, 2025