Medical Devices

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    Patrik Stollarz / Staff via Getty Images
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    Philips recall of heart monitor software tied to 109 injuries, 2 deaths

    Some electrocardiogram events, such as atrial fibrillation or abnormally rapid heartbeats, over two years were not reviewed by healthcare professionals due to a data routing issue.

    By • Jan. 14, 2025
  • Medtronic's Affera all-in-one ablation system
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    Courtesy of Medtronic
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    CEO Geoff Martha tells JPM crowd Medtronic is ‘stacking growth drivers’

    New technologies for atrial fibrillation, hypertension, diabetes and neurological conditions are poised for fast growth, Martha said Monday at the J.P. Morgan Healthcare Conference.

    By • Jan. 14, 2025
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    Sitthiphong via Getty Images
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    Trendline

    Medical device industry continues to turn to AI

    While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

    By MedTech Dive staff
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    Permission granted by Medtronic
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    CMS starts Medicare coverage analysis for Medtronic, Recor renal denervation devices

    J.P. Morgan analysts said the CMS’ review “validates the technology and could potentially move the needle on growth for Medtronic.”

    By • Jan. 14, 2025
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    libre de droit via Getty Images
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    Medtronic inks distribution deal with Contego with option to buy firm

    Medtronic will be the exclusive U.S. distributor of Contego Medical’s portfolio, which includes a carotid stent system and thrombectomy devices.

    By • Jan. 13, 2025
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    Carl Court via Getty Images
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    EU medtech regulations reducing options for patients, companies say

    Stakeholders branded the MDR and IVDR rules “unreasonably complicated,” “terrible for EU patients and doctors” and “a mess.”

    By • Jan. 13, 2025
  • Justin Spencer, new Eko Health CFO, wears a gray suit jacket and light blue shirt.
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    Courtesy of Eko Health
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    Eko Health names Justin Spencer as CFO

    Spencer’s arrival at Eko comes months after the digital health company appointed his former colleague Brent Lang to its board of directors.

    By • Jan. 10, 2025
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    Retrieved from Fire1 on January 10, 2025
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    Fire1 raises $120M to trial heart failure management system

    Medtronic and Novo Holdings were among the investors in the funding round.

    By • Jan. 10, 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 inks exclusive deal to sell Kuros bone graft device

    In the five-year agreement, Medtronic will be the exclusive sales agent for Kuros' product in certain U.S. spine geographies.

    By • Jan. 9, 2025
  • Intuitive Surgical's da Vinci 5 robotic system.
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    Courtesy of Intuitive Surgical
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    Deep Dive // 2025 outlook

    5 medtech trends to watch in 2025

    After a busy 2024, experts called out competition in soft tissue robotics, uncertainty from a Trump White House and continued success for pulsed field ablation as trends to watch this year.

    By • Jan. 9, 2025
  • A photo of Johnson & Johnson's pulsed field ablation system for atrial fibrillation.
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    Courtesy of Johnson & Johnson
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    J&J pauses Varipulse PFA cases in US

    The temporary halt to investigate reported neurovascular events comes two months after Johnson & Johnson won FDA approval for the pulsed field ablation system.

    By • Jan. 8, 2025
  • A black, square device with tubing connected to a patch is next to a phone that says "Beta Bionics" and another patch that says DexcomG6
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    Courtesy of Beta Bionics
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    Beta Bionics, maker of ‘bionic pancreas,’ files for IPO

    Beta Bionics did not disclose the number of shares it will offer or a price range.

    By • Jan. 8, 2025
  • A view of Boston Scientific's corporate headquarters in Marlborough, Massachusetts, with a clear blue sky in the background.
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    Courtesy of Boston Scientific
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    Boston Scientific to buy remaining Bolt Medical stake for up to $664M

    The deal for Bolt, developer of an intravascular lithotripsy system to treat coronary and peripheral artery disease, continues Boston Scientific’s brisk run of acquisitions.

    By • Jan. 8, 2025
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    Sarah Silbiger via Getty Images
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    FDA finalizes guidance on device shortage reporting rules

    The final version adds information on the devices affected by the guidance and the impact of revised legislation on voluntary notifications.

    By • Jan. 8, 2025
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    Elise Reuter/MedTech Dive
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    FDA aims to stem AI device bias, boost transparency in draft guidance

    The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI devices.

    By • Jan. 7, 2025
  • Outset Medical's Tablo dialysis system is shown with two people in a living room.
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    Courtesy of Outset Medical
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    Outset Medical to pay down debt after raising nearly $300M

    Stifel analyst Rick Wise said the financing, a combination of private stock placement and new loans, should help the dialysis device maker return to revenue growth.

    By • Jan. 7, 2025
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    Sarah Silbiger via Getty Images
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    FDA posts early alert about safety risk of Medline’s fluid delivery sets

    The agency issued the alert as part of a pilot to improve the timeliness of communications about actions it believes are likely to be high-risk recalls. 

    By • Jan. 6, 2025
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    TommL via Getty Images
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    Sponsored by Altium365

    Shift left today: Electronics procurement visibility for reliable device development

    Periods of uncertainty test the resolve of even the most well-oiled medical device supply chains.

    Jan. 6, 2025
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    Adam Pretty/Getty Images via Getty Images
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    Olympus begins CEO search after Kaufmann resignation

    Stefan Kaufmann, former CEO of Tokyo-based Olympus, stepped down in October after the company investigated an allegation that the executive purchased illegal drugs.

    By • Jan. 3, 2025
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    Stock via Getty Images
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    FDA closes 2024 with string of early alerts on device safety risks

    Olympus advised providers to stop using an endoscope accessory due to an infection risk linked to 120 injuries and one death.

    By • Jan. 3, 2025
  • Three white gynecological tampons on a blue background.
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    Aleksandr Grechanyuk via Getty Images
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    FDA-commissioned review finds no safety concerns linked to tampons

    Officials commissioned the independent review in September in response to a study that found tampons may expose users to metals.

    By • Jan. 3, 2025
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    Courtesy of Abbott Laboratories

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    Abbott, Dexcom settle glucose monitor patent lawsuits

    The rival companies agreed not to sue each other for the next 10 years.

    By • Jan. 2, 2025
  • Professional photo of Kolaleh Eskandanian.
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    Permission granted by Children's National Hospital
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    Q&A

    Few medical devices are designed for children. An FDA-Children’s National collaboration aims to change that.

    Kolaleh Eskandanian, chief innovation officer at Children’s National Hospital, said the partnership is meant to address the many challenges with developing devices for children and infants.

    By • Jan. 2, 2025
  • An exterior shot of the johnson and johnson logo in red outside the company's headquarters
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    Mario Tama / Staff via Getty Images
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    Top 10 medtech deals of 2024

    Multibillion-dollar buyouts returned last year, led by Johnson & Johnson’s $13.1 billion acquisition of Shockwave Medical.

    By • Jan. 2, 2025
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    Courtesy of Edwards Lifesciences
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    CMS proposes Medicare coverage for transcatheter tricuspid replacement

    Edwards submitted a request for a national coverage determination in February, after receiving FDA approval for its Evoque device earlier that month.

    By • Updated Dec. 23, 2024
  • CMR Surgical Co-founder and CMO Mark Slack stands with his arms crossed in front of a Versius robot.
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    Permission granted by CMR Surgical
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    Robots, AI and PFA: The top medtech Q&As of 2024

    From challenging market leaders to the growing influence of artificial intelligence, medical device executives had a lot to discuss this year. Check out MedTech Dive’s top Q&As of 2024.

    By • Dec. 20, 2024