Medical Devices

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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.

    By • Oct. 1, 2025
  • 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.

    By • Oct. 1, 2025
  • Boston Scientific's Farapulse pulsed field ablation device. Explore the Trendline➔
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    Trendline

    New medical devices are reshaping the medtech industry

    From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

    By MedTech Dive staff
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    Sean Pavone via 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.

    By • Oct. 1, 2025
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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.

    By • Sept. 30, 2025
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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.

    By • Sept. 29, 2025
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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.

    By • Sept. 29, 2025
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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.

    By • Updated Sept. 29, 2025
  • The SS Innovations SSi Mantra robot's five modular arms and surgeon console are shown.
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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.

    By • Sept. 26, 2025
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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.

    By • Sept. 26, 2025
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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.

    By • Sept. 26, 2025
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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.

    By • Sept. 25, 2025
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    US opens investigation into medical equipment, device imports

    As part of the Section 232 probe, the Trump administration will weigh the need for tariffs on goods such as surgical masks, blood glucose monitors and wheelchairs.

    By Philip Neuffer • Sept. 25, 2025
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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.

    By • Sept. 25, 2025
  • A physician sits at the console of Medtronic's Hugo robotic surgery system.
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    Medtronic expands AI, robotics hub in London; Virtuoso robot gets FDA breakthrough status

    The Medtronic center will facilitate surgeon collaboration and AI-powered decision support. At Virtuoso Surgical, a robotic approach to bladder lesion removal is expected to improve precision.

    By • Sept. 24, 2025
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    magicmine via Getty Images
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    Cardiosense names Eric Meizlish as CEO

    Cardiosense’s switch to a leader with experience scaling healthtech companies comes as it works to build on the recent 510(k) clearance of CardioTag.

    By • Updated Sept. 25, 2025
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    Courtesy of Abiomed
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    J&J’s Abiomed starts third heart pump controller recall since June

    As of Aug. 27, the company had reported five serious injuries and no deaths associated with the issue.

    By • Sept. 24, 2025
  • J&J's Linx device to treat gastroesophageal reflux disease
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    Retrieved from Johnson & Johnson on September 23, 2025
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    J&J exits Linx esophageal reflux business in some countries

    Johnson & Johnson, which said it made the decision based on a market assessment, did not specify the markets it is leaving or provide a timeline. Linx will remain available in the U.S.

    By • Updated Sept. 24, 2025
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    Olympus removes needles after patient death

    Olympus is recalling certain lots of needles, used for lung cancer biopsy, because components can detach during procedures.

    By • Updated an hour ago
  • A modern two-story commercial office building with a mix of gray and wood paneling on the exterior. Large glass windows dominate both floors, and the front entrance features the "Medtronic" logo above double glass doors. The surrounding area includes a few small shrubs and empty parking spaces in front.
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    Medtronic wins FDA approval for urinary incontinence device

    Analysts said Altaviva is an attractive option compared to rival products, informing their belief that Medtronic can capitalize on a large market opportunity.

    By • Sept. 22, 2025
  • SS Innovations CEO Sudhir Srivastava is seated at the surgeon's console of the company's SSi Mantra robotic surgery system.
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    Profile

    How SS Innovations is expanding robotic surgery’s reach

    Heart surgeon Sudhir Srivastava saw a global need for less-invasive surgical care at an affordable price. His company, SS Innovations, built a robot that has now been used in more than 5,000 surgeries.

    By • Sept. 22, 2025
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    Exactech agrees to $8M settlement over defective knee implants

    The payment resolves allegations brought by the Department of Justice that Exactech violated the False Claims Act by selling knee implants with components that failed prematurely.

    By • Sept. 19, 2025
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    FDA posts early alert about Abbott’s Tactiflex Ablation Catheter

    Catheter tips came off three damaged devices during surgery but none of the patients suffered serious injuries or died.

    By • Updated Sept. 22, 2025
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    Courtesy of Johnson & Johnson
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    J&J launches IVL device in Europe; Medtronic looks at pacing for more patients

    J&J’s Shockwave Javelin intravascular lithotripsy catheter treats people with peripheral artery disease. Elsewhere, Medtronic began a pivotal trial to evaluate its pacemakers in a new patient group.

    By • Sept. 18, 2025
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    House committee advances Medicare coverage bill for breakthrough devices

    AdvaMed welcomed the committee’s work on the legislation but called for the inclusion of diagnostics in the bill.

    By • Sept. 18, 2025
  • Food And Drug Administration Headquarters In Maryland
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    FDA warns on unauthorized blood pressure, infant monitoring devices

    Many of these devices currently sold over-the-counter do not have marketing authorization, the agency said in a notice.

    By • Updated Sept. 18, 2025