Medical Devices: Page 11

  • Two business people signing a contract
    Image attribution tooltip
    simarik via Getty Images
    Image attribution tooltip

    Owens & Minor inks $375M deal to sell unit to investment firm

    The sale will leave Owens & Minor focused on a smaller but potentially faster-growing and higher-margin business that provides products directly to patients.

    By • Oct. 8, 2025
  • A picture of a man in a suit delivering a speech in front of a blue background.
    Image attribution tooltip
    Elise Reuter/MedTech Dive
    Image attribution tooltip

    AdvaMed CEO: ‘Just give us some certainty’

    At AdvaMed’s annual conference, CEO Scott Whitaker addressed policy issues around tariffs, FDA staff cuts and the government shutdown.

    By • Oct. 8, 2025
  • Intuitive Surgical's da Vinci 5 robotic system. Explore the Trendline➔
    Image attribution tooltip
    Courtesy of Intuitive Surgical
    Image attribution tooltip
    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 in a blue jacket holds a microphone and gestures as they speak.
    Image attribution tooltip
    Elise Reuter/MedTech Dive, data from MedTech Dive
    Image attribution tooltip

    How 4 medtech CEOs are using AI

    At AdvaMed’s The MedTech Conference, executives said they’re incorporating AI in more devices, but figuring out how to use the technology internally is challenging.

    By • Oct. 7, 2025
  • Convatec's Boston facility is shown with a blue sky above.
    Image attribution tooltip
    Permission granted by Convatec
    Image attribution tooltip

    Convatec plans $1B investment in R&D in the US and UK

    Capacity at the company's Boston site will increase by 50% as part of a $600 million, 10-year commitment to the U.S.

    By • Oct. 7, 2025
  • Robotic arm with blue light working in factory
    Image attribution tooltip

    AdobeStock/Eakdent

    Image attribution tooltip
    Sponsored by Arena

    How AI-driven supply chain intelligence is transforming medical device manufacturing

    AI-powered supply chain intelligence helps MedTech firms overcome EOL risks and regulatory hurdles.

    Oct. 6, 2025
  • An exterior shot of a building stretching over a road next to a river, with the words "Hospital for Special Surgery" on the side.
    Image attribution tooltip
    Courtesy of Hospital for Special Surgery
    Image attribution tooltip
    Q&A

    Hospital for Special Surgery’s Ashis Barad says AI must solve real problems

    Barad, chief digital and technology officer at HSS, outlined his approach to evaluating AI tools and how the orthopedic hospital uses the technology.

    By • Oct. 3, 2025
  • The exterior of Medtronic's Minnesota operational headquarters is shown along with its reflection in a pool of water.
    Image attribution tooltip
    Courtesy of Medtronic
    Image attribution tooltip

    Medtronic wins CE mark for Penditure LAA exclusion device

    The company plans to launch the device in Europe late next week, providing competition for AtriCure’s AtriClip product.

    By • Oct. 3, 2025
  • A sign for the FDA is shown in front of the headquarters building in Silver Spring, Maryland.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    CDRH shares regulatory guidance priorities for the coming 12 months

    Use of real-world evidence to support regulatory decisions and predetermined change control plans for medical devices are two areas of focus for the agency.

    By • Oct. 2, 2025
  • The SS Innovations SSi Mantra robotic system.
    Image attribution tooltip
    Permission granted by SS Innovations
    Image attribution tooltip

    SS Innovations changes course on FDA filing for soft tissue robot

    A 510(k) submission now planned for this quarter sets up a potentially faster clearance than the de novo pathway originally planned, the company said.

    By • Oct. 2, 2025
  • Boston Scientific's Farapulse pulsed field ablation device.
    Image attribution tooltip
    Permission granted by Boston Scientific
    Image attribution tooltip

    Boston Scientific aims for market leadership in electrophysiology

    The company has now treated 500,000 patients with its pulsed field ablation system, in a competitive category poised for growth.

    By • Oct. 2, 2025
  • Two clinicians operate Distalmotion's Dexter robotic system in an operating room.
    Image attribution tooltip
    Permission granted by Distalmotion
    Image attribution tooltip

    Distalmotion adds hysterectomy indication; AiM raises funds for neurosurgical robot

    The clearance gives Distalmotion, which sees opportunity in ambulatory settings, a third robotic procedure category in the U.S. Elsewhere, AiM Medical Robotics raised $8.1 million.

    By • Oct. 2, 2025
  • A modern architectural design building featuring a red-brick façade with large glass windows displays a prominent sign of the Food and Drug Administration.
    Image attribution tooltip
    Alamy
    Image attribution tooltip

    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 rendering of a rounded device with a wire structure surrounded by mesh.
    Image attribution tooltip
    Courtesy of Boston Scientific
    Image attribution tooltip

    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 • Updated Oct. 14, 2025
  • A picture of Boston's skyline and Quincy Market at dusk
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    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 • Updated Jan. 28, 2026
  • FDA headquarters sign
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Alamy
    Image attribution tooltip

    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
  • Letters appear clearer in an eye chart on a yellow wall viewed through glasses.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Courtesy of Biolinq
    Image attribution tooltip

    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.
    Image attribution tooltip
    Permission granted by SS Innovations
    Image attribution tooltip

    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.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Justin Sullivan via Getty Images
    Image attribution tooltip

    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
    Image attribution tooltip
    Courtesy of HeartFlow
    Image attribution tooltip

    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.
    Image attribution tooltip
    Chip Somodevilla via Getty Images
    Image attribution tooltip

    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 Phil Neuffer • Sept. 25, 2025
  • Professional photo of Que Dallara
    Image attribution tooltip
    Permission granted by Medtronic
    Image attribution tooltip
    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.
    Image attribution tooltip
    Permission granted by Medtronic
    Image attribution tooltip

    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