The Latest

  • Illustration of a blood clot blocking red blood cells within an artery or a vein.
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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.

  • A sign that says Illumina is on a curb in front of red brick buildings.
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    Courtesy of Illumina
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    Illumina, Nvidia team to use AI in foundation models

    Nvidia’s partnership with the gene sequencing company is one of several healthcare collaborations revealed Monday by the computing giant.

  • Blue and yellow flags bearing the European Commission logo fly in front of a building.
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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.”

  • 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.

  • An embpty bed is surrounded by monitors and hospital equipment.
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    Martin Barraud via Getty Images
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    More hospitals need to assess predictive models for accuracy, bias: Health Affairs

    Just 61% of hospitals surveyed evaluated models for accuracy on their own data, and less than half evaluated the models for bias.

    AI
  • 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.

  • A picture of a person in a dark yellow seater holding their smartphone and looking at their health data.
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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.

  • 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.

  • 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.

  • 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.

  • 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.

  • A sign reading Food and Drug Administration is seen above a door to a government building.
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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.

  • A picture of a large building with the name "Stryker" across it and a pond with a swan in the foreground.
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    Retrieved from Stryker Corporation on January 06, 2025
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    Stryker to buy Inari Medical for nearly $5B

    Stryker made several small deals last year but lacked a larger acquisition like its nearly $5 billion proposal for Inari Medical.

    M&A
  • A person sits on a white couch and speaks.
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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.

  • 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.

  • A doctor puts a pulse oximeter on a patient's finger
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    Wavebreakmedia via Getty Images
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    FDA issues much-anticipated guidance on pulse oximeters

    The FDA released the guidance in response to concerns that the devices are less accurate in people with darker skin pigmentation.

    FDA
  • Front sign of FDA building
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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.