Medical Devices: Page 13

  • A sign for the FDA is shown in front of the headquarters building in Silver Spring, Maryland.
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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
  • 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
  • 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
  • A person sets a brown, paper bag on a counter and holds another bag. They are wearing a white wristband.
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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
  • Recruitment or leadership concept. People row with spotlight highlighted one - creative visualization of people challenge competition
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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
  • Professional photo of Spencer Stiles
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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
  • FDA headquarters sign
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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
  • A warehouse with rows of packages
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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
  • Becton Dickinson logo
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    Permission granted by Becton Dickinson
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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
  • CMS Administrator Dr. Mehmet Oz speaks at an Aspen Institute event.
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    Permission granted by Aspen Institute
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    CMS finalizes competitive bidding changes to diabetes devices

    AdvaMed supported adjustments made from a draft version but still has concerns about the impact on patient access.

    By • Dec. 1, 2025
  • The Johnson & Johnson logo is displayed at company offices on October 17, 2023, in Irvine, California.
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    Mario Tama via Getty Images
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    J&J’s US orthopedic leader leaves amid DePuy spinout process

    Leslie Storms started a new role on Monday as president of Ethos Veterinary Health.

    By • Dec. 1, 2025
  • A surgeon in Nebraska operates a robot to cut a rubber band on the International Space Station in a simulated surgical procedure.
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    Retrieved from Craig Chandler / University Communication and Marketing / University of Nebraska-Lincoln on November 26, 2025
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    Profile

    Building a better robot: How Virtual Incision plans to challenge Intuitive

    Led by former Intuitive executive Jim Alecxih, Virtual Incision expects the miniaturized design of its robot to stand out in an increasingly crowded field of challengers.

    By • Dec. 1, 2025
  • A person wearing a white, round patch on their upper arm holds a phone.
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    Getty Images
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    OIG report finds Medicare overpaying for CGMs and supplies

    The CMS could use its competitive bidding program to address price concerns, after payments for the devices swelled over five years, the government watchdog said.

    By • Nov. 26, 2025
  • The facade of the U.S. Capitol building is seen along with trees and a reflection pond
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    Kara Arundel/MedTech Dive
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    Lawmakers propose Medicare reimbursement pathway for AI devices

    AdvaMed supports the legislation, which is intended to ensure AI-enabled devices receive an accurate CMS payment code.

    By • Nov. 26, 2025
  • Boston Scientific's Farawave pulsed field ablation catheter is shown against a white background.
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    Courtesy of Boston Scientific
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    CMS covers cardiac ablation in ambulatory surgery centers

    Extending Medicare reimbursement for cardiac catheter ablation to settings outside the hospital is expected to boost procedure volumes and benefit Abbott, Boston Scientific, J&J and Medtronic.

    By • Nov. 26, 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 taps Jim Peichel as CTO

    Peichel, who has worked at Medtronic for more than 25 years, succeeds Ken Washington, who retired earlier this month.

    By • Nov. 25, 2025
  • FDA sign
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    Ceribell wins FDA clearance for seizure-detection algorithm in neonates

    By acquiring new accounts and expanding into NICUs managed by existing clients, Ceribell calculates it can unlock a $400 million market.

    By • Nov. 25, 2025
  • A person on a stationary bike wears a small, white patch on their upper arm.
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    Permission granted by Abbott Laboratories
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    Abbott issues correction for millions of glucose sensors

    The problem applies to Abbott’s Libre 3 and Libre 3 Plus sensors. The company said it has received reports of 736 severe adverse events and seven deaths.

    By • Nov. 24, 2025