Medical Devices: Page 5

  • BD CFO Chris DelOrefice wears a suit and tie in a headshot.
    Image attribution tooltip
    Courtesy of BD
    Image attribution tooltip

    BD CFO Chris DelOrefice leaving for new job

    Along with DelOrefice’s departure, BD reported preliminary fiscal fourth-quarter revenue that analysts said was below Wall Street consensus expectations.

    By • Oct. 16, 2025
  • The US and Canada flags wave in front of a bridge
    Image attribution tooltip
    Bill Pugliano via Getty Images
    Image attribution tooltip

    To move or not to move? Manufacturers hesitant to nearshore before USMCA review

    While some companies are using regional supply chains or leaning on tariff exemptions by maximizing compliance, others are frozen in place.

    By Shefali Kapadia • Oct. 16, 2025
  • Boston Scientific's Farapulse pulsed field ablation device. Explore the Trendline➔
    Image attribution tooltip
    Permission granted by Boston Scientific
    Image attribution tooltip
    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
  • 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.
    Image attribution tooltip
    Alamy
    Image attribution tooltip

    Abbott CEO: ‘We’re right on time’ to the PFA party

    As competitors have launched their first pulsed field ablation devices in the U.S., Abbott CEO Robert Ford told investors that the company is not just playing defense.

    By • Oct. 15, 2025
  • An anatomical heart is pictured in red in a transparent body.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Stereotaxis teams with CardioFocus to develop robotic PFA system

    Stereotaxis CEO David Fischel said the precision, stability and safety profile of robotics are a good fit for pulsed field ablation.

    By • Oct. 15, 2025
  • Five people sit in white chairs on a stage. One of them, the second from the left, is speaking.
    Image attribution tooltip
    Elise Reuter/MedTech Dive, data from MedTech Dive
    Image attribution tooltip

    5 AI takeaways from AdvaMed’s conference

    Medical device firms discussed privacy, regulations and prioritizing projects as AI becomes more prevalent in the industry.

    By • Oct. 14, 2025
  • illustration of a heart showing a tube-shaped device going into the left ventricle
    Image attribution tooltip
    Courtesy of Abiomed
    Image attribution tooltip

    Cybersecurity triggers another recall of J&J’s Impella heart pump controller

    While no patients have been harmed, the FDA categorized the action as a Class I recall because of the potential for serious injury or death.

    By • Oct. 14, 2025
  • Two people view Medtronic's Hugo robotic surgery system in an operating room.
    Image attribution tooltip
    Courtesy of Medtronic
    Image attribution tooltip

    Intuitive’s challengers continue to advance

    Companies creating new robotic platforms marked additional milestones heading into the fourth quarter. Catch up with their progress in this roundup of the latest developments in surgical robotics.

    By • Oct. 10, 2025
  • An x-ray image of the ankle and foot.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Zimmer launches 2 devices from $1.1B orthopedic takeover

    After acquiring Paragon 28 earlier this year, Zimmer intends to maintain the foot and ankle specialist’s double-digit growth.

    By • Oct. 10, 2025
  • Three people view Intuitive Surgical's Ion robotic system during a procedure setup.
    Image attribution tooltip
    Courtesy of Intuitive Surgical
    Image attribution tooltip

    Intuitive expands AI in Ion; Horizon performs first robotic cataract surgery

    The FDA cleared AI and imaging updates for Intuitive’s lung biopsy robot. Elsewhere, Horizon completed the first cataract surgery with its robotic system, and MMI began a neurosurgical study.

    By • Oct. 10, 2025
  • A person sits on a white chair with a blue background.
    Image attribution tooltip
    Elise Reuter/MedTech Dive, data from MedTech Dive
    Image attribution tooltip

    FDA’s presence at AdvaMed conference shrinks amid shutdown

    Michelle Tarver, director of the Center for Devices and Radiological Health, and other center officials attended virtually as a government shutdown continues.

    By • Oct. 9, 2025
  • Three clinicians in surgical garb view the screen at the console of Medtronic's Hugo robotic surgery system.
    Image attribution tooltip
    Courtesy of Medtronic
    Image attribution tooltip

    Medtronic begins study of Hugo robot in gynecology

    With positive trial results in urology and hernia repair already under its belt, the company is getting closer to taking on Intuitive Surgical in the U.S. robotic surgery market.

    By • Oct. 9, 2025
  • 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
  • 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
  • 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
  • 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 • Oct. 1, 2025