Medical Devices: Page

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    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
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    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
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    Trendline

    Top 5 stories from MedTech Dive

    From the effects of layoffs at the Food and Drug Administration and President Donald Trump’s tariff policies to the top medtech trends of 2026, here is a collection of top stories from MedTech Dive.

    By MedTech Dive staff
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    Elise Reuter/MedTech Dive, data from MedTech Dive
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    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
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    Courtesy of Abiomed
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    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.
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    Courtesy of Medtronic
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    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
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    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.
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    Courtesy of Intuitive Surgical
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    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
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    Elise Reuter/MedTech Dive, data from MedTech Dive
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    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.
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    Courtesy of Medtronic
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    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
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    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
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    Elise Reuter/MedTech Dive
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    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
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    Elise Reuter/MedTech Dive, data from MedTech Dive
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    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
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    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
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    AdobeStock/Eakdent

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    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
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    Courtesy of Hospital for Special Surgery
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    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
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    Courtesy of Medtronic
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    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
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    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
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    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.
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    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.
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    Permission granted by Distalmotion
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    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
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    Alamy
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    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
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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.

    By • Updated Oct. 14, 2025
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    Top medtech conferences in 2026

    After a busy first half of the year, there are still plenty of medtech events to look forward to, including AdvaMed’s annual meeting in Boston.

    By • Updated June 29, 2026
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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.

    By • Sept. 30, 2025
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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.

    By • Sept. 29, 2025