Medical Devices: Page 6

  • 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.

    By • Sept. 30, 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.

    By • Sept. 29, 2025
  • Boston Scientific's Farapulse pulsed field ablation device. Explore the Trendline➔
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    Permission granted by Boston Scientific
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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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    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
  • 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.

    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
  • EU flags in front of the Berlaymont building, headquarters of the European Commission in Brussels, Belgium.
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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
  • 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.

    By • Sept. 26, 2025
  • 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.

    By • Sept. 25, 2025
  • President Donald Trump leaves the 80th session of the United Nations General Assembly at the UN headquarters on Sept. 23, 2025, in New York City.
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    Chip Somodevilla via Getty Images
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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
  • 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.

    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
  • An anatomical heart is pictured in red in a transparent body.
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    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
  • illustration of a heart showing a tube-shaped device going into the left ventricle
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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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    Sarah Silbiger via Getty Images
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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 Oct. 1, 2025
  • 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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    Alamy
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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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    Permission granted by SS Innovations
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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
  • A patient recovers after a total knee replacement surgery.
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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
  • 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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    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
  • A wall bearing the Johnson & Johnson logo is seen outside of an office building.
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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
  • A man exits the front of the U.S. Capitol at dawn.
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    Win McNamee via Getty Images
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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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    Sarah Silbiger via Getty Images
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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
  • A picture of Siemens Healthineers' headquarters building in Erlangen, Germany.
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    Courtesy of Siemens Healthineers
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    Stryker, Siemens Healthineers partner on neurovascular robot

    The companies will develop a robotic system to improve patient outcomes in complex hemorrhagic cases and time-sensitive ischemic strokes.

    By • Sept. 17, 2025
  • Becton Dickinson logo
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    BD expands Class I recall to cover 15 more Alaris pump infusion sets

    BD, which has not received any complaints related to the issue, previously discontinued the devices affected by the expanded recall.

    By • Sept. 17, 2025
  • Professional photo of Flavia Pease
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    Retrieved from Insulet on September 16, 2025
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    Insulet names new CFO; Dexcom CEO on leave

    Flavia Pease will take over as Insulet’s CFO on Sept. 30. Elsewhere, outgoing Dexcom CEO Kevin Sayer is taking a medical leave of absence.

    By • Sept. 16, 2025