The Latest

  • 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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    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
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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
  • 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.

  • A lab technician runs Guardant Health's Shield blood test for colorectal cancer screening in a lab.
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    Courtesy of Business Wire
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    Quest to distribute Guardant colon cancer blood test

    Guardant Health Co-CEO AmirAli Talasaz also unveiled plans to launch the Shield test for multi-cancer detection in October.

  • 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.

  • A physician sits at the console of Medtronic's Hugo robotic surgery system.
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    Permission granted by Medtronic
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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.

  • 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.

  • 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.

    Updated Sept. 25, 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.

  • 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.

    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.

    Updated Oct. 1, 2025
  • Test tube blood
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    Getty Images
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    Multi-cancer blood tests aren’t ready for routine use, review says

    Research funded by the Agency for Healthcare Research and Quality found insufficient evidence to determine the accuracy — or possible harm — of the cancer screenings.

  • President Donald Trump holds a copy of a 2025 National Trade Estimate Report
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    Chip Somodevilla via Getty Images
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    White House asks Supreme Court to uphold Trump’s tariff powers

    The government submitted a 49-page brief urging the high court to affirm Trump's broad emergency levies.

    Updated Sept. 22, 2025