Medical Devices: Page 7

  • Professional photo of Josh Makower
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    Permission granted by DaVita
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    Dialysis cannulation can be difficult. A startup is working to improve it.

    X9 is building an ultrasound-guided device used to simplify the process of inserting a needle for cannulation.

    By • Dec. 17, 2025
  • Edwards Lifesciences' Sapien 3 Ultra heart valve replacement system is shown with the valve expanded by a balloon.
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    Courtesy of Edwards Lifesciences
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    CMS considers expanding TAVR coverage to asymptomatic patients

    Medicare reimbursement for aortic stenosis patients without symptoms could accelerate procedure growth for Edwards Lifesciences, which requested the CMS review, analysts said.

    By • Dec. 16, 2025
  • Intuitive Surgical's da Vinci 5 robotic system. Explore the Trendline➔
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    Courtesy of Intuitive Surgical
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    Trendline

    Top 5 stories from MedTech Dive

    From the top medtech trends to watch in 2026 to haphazard layoffs at the Food and Drug Administration and the evolving use of AI in the medtech sector, here is a collection of top stories from MedTech Dive.

    By MedTech Dive staff
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    FDA gets mixed feedback on performance monitoring for AI

    Medtech industry groups said the FDA should use existing regulatory and quality tools to monitor performance, while medical groups said device manufacturers should be responsible for monitoring AI.

    By • Dec. 16, 2025
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    Courtesy of Philips
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    Philips to acquire SpectraWAVE

    SpectraWAVE makes technologies to help diagnose and guide treatment decisions for coronary artery disease.

    By • Dec. 15, 2025
  • A sign for the FDA is shown in front of the headquarters building in Silver Spring, Maryland.
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    Getty Images
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    FDA needs more staff, authority to oversee device recalls, watchdog finds

    “FDA's challenges — such as insufficient staffing — can create inefficiencies in the process and potentially put lives at risk,” the U.S. Government Accountability Office said.

    By • Dec. 15, 2025
  • AtriCure’s EnCompass Clamp device is shown against a white background.
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    Retrieved from AtriCure on December 12, 2025
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    AtriCure treats first patients with dual PFA/RF system

    Combining pulsed field ablation and a radiofrequency technique in one platform is expected to reduce procedure times.

    By • Dec. 12, 2025
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    Elise Reuter/MedTech Dive, data from MedTech Dive
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    Mick Farrell named chair of AdvaMed board

    The Resmed CEO will serve a two-year term on the medtech lobbying group’s board.

    By • Dec. 12, 2025
  • An anatomical heart is pictured in red in a transparent body.
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    Impulse Dynamics raises $158M to commercialize heart failure device

    By strengthening heart contractions, Impulse’s device could improve quality of life, restore functional capacity and enhance tolerance for exercise. 

    By • Dec. 11, 2025
  • A modern office building with large reflective glass windows is shown behind a wide driveway and landscaped entrance. In the foreground, a white and orange monument sign reads "Intuitive Surgical" with the number "1020" vertically on the side.
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    Alamy
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    Intuitive wins 3 new indications for da Vinci SP system

    The robotic surgery market leader’s single port system can now be used in inguinal hernia repair, gallbladder removal and appendectomy procedures.

    By • Dec. 11, 2025
  • A sign for the FDA is shown in front of the headquarters building in Silver Spring, Maryland.
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    Getty Images
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    FDA pilots allowing digital health devices access to CMS payment program

    Companies can ask the FDA to waive premarket authorization and investigational device requirements while they collect real-world data in a CMS program.

    By • Dec. 10, 2025
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    simarik via Getty Images
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    Teleflex inks deals to sell 3 businesses for $2B

    Needham analysts said Teleflex’s inability to secure a price above the low end of their expectations could reflect “the continued poor performance of UroLift.”

    By • Dec. 10, 2025
  • A person covered by a blue sheet lays flat under a rectangular, white tube.
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    Courtesy of Mayo Clinic
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    GE HealthCare, Mayo Clinic expand partnership around radiology research

    Ben Newton, GE HealthCare’s global head of oncology, said the partnership will shift radiation therapy from a “one-size-fits-all” approach to a personalized method.

    By • Dec. 9, 2025
  • 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 changes investor relations leadership ahead of diabetes spinout

    Ryan Weispfenning has elected to take up the challenge of creating and leading the investor relations function at the planned new diabetes company.

    By • Dec. 9, 2025
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    Courtesy of Whoop
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    Deep Dive

    What medtech firms can learn from Whoop’s warning letter

    An FDA warning letter about the wearable company’s blood pressure feature raises questions about the blurring lines between medtech and wellness.

    By • Dec. 8, 2025
  • The SS Innovations SSi Mantra robotic system.
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    Permission granted by SS Innovations
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    SS Innovations submits robotic system for FDA clearance

    After introducing its robot in multiple countries outside the U.S., including India, the company turns its focus to the world’s largest robotic surgery market.

    By • Dec. 8, 2025
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    Dmitry Kovalchuk
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    Olympus-backed Swan EndoSurgical names Erik Todd as CEO

    Swan highlighted Todd’s experience in scaling robotic platforms, building global engineering organizations and driving innovation across endoscopy and minimally invasive surgery.

    By • Dec. 5, 2025
  • V-Wave's implantable device for heart failure is shown next to a dime.
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    Permission granted by Johnson & Johnson
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    FDA advisory panel votes unanimously against J&J heart shunt

    Panelists focused on study data that showed the implant did not improve outcomes in heart failure patients.

    By • Dec. 5, 2025
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    Courtesy of Stryker
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    Stryker names Spencer Stiles as COO

    Stiles has worked at Stryker for 27 years, most recently leading the company’s orthopedics business.

    By • Dec. 4, 2025
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    Getty Images
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    Olympus reinforces advice over device issue linked to 113 serious injuries

    The company received complaints that the ligation loop can become unintentionally anchored in place.

    By • Dec. 4, 2025
  • Medtronic's Hugo robotic surgery system is shown in an operating room in Seoul, South Korea, with a surgical team.
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    Courtesy of Medtronic
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    Medtronic’s Hugo surgical robot earns FDA clearance

    With the U.S. authorization for urologic procedures, “there is now choice” for hospitals that want to expand their robotic programs, a company executive said.

    By • Dec. 4, 2025
  • A person stands outside wearing a small, square device with a cord on their belt.
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    Permission granted by Medtronic
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    Medtronic launches insulin delivery system with Abbott-made sensor

    The partnership is the first time Medtronic has integrated its insulin pumps with a sensor developed outside of the company.

    By • Dec. 3, 2025
  • Illustration of a blood clot blocking red blood cells within an artery or a vein.
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    Getty Images
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    Akura Medical raises $53M to advance thrombectomy portfolio

    Part of the money will go toward setting up a joint venture in Qatar, whose sovereign wealth fund led the round.

    By • Dec. 3, 2025
  • 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 names Jeb Denny as chief medical officer for acute care and monitoring

    Denny leads the unit after Medtronic combined its patient monitoring and respiratory businesses last year.

    By • Dec. 3, 2025
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    Courtesy of Medline
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    PitchBook: AI tuck-in deals to drive M&A acceleration in 2026

    Buyers will focus on “tuck-ins that add AI or data-driven capabilities or can meaningfully improve scale against emerging competitors,” the analysts said.

    By • Dec. 3, 2025
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    FDA flags risk from dropped BD Alaris pumps after 2 injury reports

    BD told customers to immediately remove from use any devices they drop or severely jar.

    By • Dec. 2, 2025