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  • A picture of Boston's skyline and Quincy Market at dusk
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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.

  • Convatec's Boston facility is shown with a blue sky above.
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    Permission granted by Convatec
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    Convatec plans $1B investment in R&D in the US and UK

    Capacity at the company's Boston site will increase by 50% as part of a $600 million, 10-year commitment to the U.S.

  • A close-up shot of a woman's hands, handling a syringe of insulin.
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    Getty Images
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    Revvity, Sanofi team on early Type 1 detection; Kihealth raises funds for diabetes test rollout

    The Sanofi partnership will support clinical validation and regulatory submissions for Revvity’s new assay. Elsewhere, Kihealth raised $5 million in seed funding to launch its early detection test.

  • An exterior shot of a building stretching over a road next to a river, with the words "Hospital for Special Surgery" on the side.
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    Courtesy of Hospital for Special Surgery
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    Q&A

    Hospital for Special Surgery’s Ashis Barad says AI must solve real problems

    Barad, chief digital and technology officer at HSS, outlined his approach to evaluating AI tools and how the orthopedic hospital uses the technology.

  • 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 Penditure LAA exclusion device

    The company plans to launch the device in Europe late next week, providing competition for AtriCure’s AtriClip product.

  • Side view portrait of doctor and patient talking in a clinic setting.
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    Getty Images
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    Deep Dive

    AI could transform healthcare. Can safety-net providers keep up?

    Implementing artificial intelligence requires significant human labor and technical expertise, threatening to create a digital divide between highly resourced health systems and safety-net providers.

    AI
  • A sign for the FDA is shown in front of the headquarters building in Silver Spring, Maryland.
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    CDRH shares regulatory guidance priorities for the coming 12 months

    Use of real-world evidence to support regulatory decisions and predetermined change control plans for medical devices are two areas of focus for the agency.

  • The SS Innovations SSi Mantra robotic system.
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    Permission granted by SS Innovations
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    SS Innovations changes course on FDA filing for soft tissue robot

    A 510(k) submission now planned for this quarter sets up a potentially faster clearance than the de novo pathway originally planned, the company said.

  • Boston Scientific's Farapulse pulsed field ablation device.
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    Permission granted by Boston Scientific
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    Boston Scientific aims for market leadership in electrophysiology

    The company has now treated 500,000 patients with its pulsed field ablation system, in a competitive category poised for growth.

  • Two clinicians operate Distalmotion's Dexter robotic system in an operating room.
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    Permission granted by Distalmotion
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    Distalmotion adds hysterectomy indication; AiM raises funds for neurosurgical robot

    The clearance gives Distalmotion, which sees opportunity in ambulatory settings, a third robotic procedure category in the U.S. Elsewhere, AiM Medical Robotics raised $8.1 million.

  • 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 closeup of Boston Scientific's Watchman FLX device is shown against a white background.
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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.

  • 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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    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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    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
  • A ship labeled "Matson" carries several large boxes in front of a port.
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    Justin Sullivan via Getty Images
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    Section 232 probe reignites tariff uncertainty for medtech firms

    The Trump administration has used the investigations in other sectors to implement tariffs, but the earliest any potential actions would take place is summer 2026, analysts said.

  • Professional photo of Que Dallara
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    Permission granted by Medtronic
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    Q&A

    Que Dallara on Medtronic’s diabetes spinoff, pipeline and Abbott partnership

    Dallara, president of Medtronic’s diabetes business, discussed the segment’s turnaround and why she sees a benefit in becoming a standalone firm.

  • Heartflow
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    Courtesy of HeartFlow
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    Heartflow receives FDA clearance for updated plaque analysis platform

    The updated algorithm shows a 21% improvement in plaque detection, compared to the original version.