The Latest

  • The entrance to Illumina's San Diego campus.
    Image attribution tooltip
    Courtesy of Illumina
    Image attribution tooltip

    Illumina wins FDA approval for companion diagnostic cancer test

    Physicians can use the test to identify people eligible for treatment with Bayer’s Vitrakvi and Eli Lilly’s Retevmo, which target cancers that have specific genetic features.

  • A photo shows Insulet Chief Medical Officer Trang Ly
    Image attribution tooltip
    Permission granted by Insulet
    Image attribution tooltip
    Q&A

    Insulet’s Trang Ly on overcoming ‘clinical inertia’ in diabetes care

    Automated insulin delivery for Type 2 patients can help change minds among physicians who have been reluctant to prescribe pump therapy, the chief medical officer said in an interview.

  • A view of Boston Scientific's corporate headquarters in Marlborough, Massachusetts, with a clear blue sky in the background.
    Image attribution tooltip
    Courtesy of Boston Scientific
    Image attribution tooltip

    Boston Scientific receives CE mark for updated TAVR technology

    Changes include the addition of a larger valve size that company executives have said will open up 25% of the market in Europe.

  • Two employees work in a clean room pictured through a window at UFP Technologies' Grand Rapids, Michigan, facility.
    Image attribution tooltip
    Retrieved from UFP Technologies on August 27, 2024
    Image attribution tooltip

    UFP to buy device component maker AQF Medical, extending deal spree

    AQF makes foam and thermoplastic components for use in medical devices and packaging.

  • A person runs in a soccer field wearing two white devices taped to their upper arms.
    Image attribution tooltip
    Courtesy of Insulet
    Image attribution tooltip

    Insulet expands Omnipod 5 pump to people with Type 2 diabetes

    The FDA clearance marks the first automated insulin delivery system for people with Type 2 diabetes.

  • A 3D visualization of red blood cells traveling through a blood vessel.
    Image attribution tooltip
    Kahan Shan via Getty Images
    Image attribution tooltip

    Inari updates label of clot removal device linked to 6 deaths

    Inari recalled the catheter and revised instructions for use after reports of the device becoming entrapped or blocking patients’ lung arteries.

  • A picture of Siemens Healthineers' headquarters building in Erlangen, Germany.
    Image attribution tooltip
    Courtesy of Siemens Healthineers
    Image attribution tooltip

    Siemens Healthineers to grow PET imaging with purchase of Novartis assets

    Siemens will pay 200 million euros for the manufacturing and distribution network of Novartis’ radiopharmaceutical molecular imaging business.

  • A person playing pickleball wears a circular patch on their upper arm.
    Image attribution tooltip
    Courtesy of Dexcom
    Image attribution tooltip

    Dexcom prices first over-the-counter glucose monitor

    Known as Stelo, the device is intended for people who don’t take insulin and costs $89 per month.

  • FDA headquarters with sign in foreground
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    FDA seeks feedback on predetermined change control plans

    The guidance describes changes companies can make to medical devices without filing a new 510(k) or premarket approval supplement.

  • A sign reading Food and Drug Administration is seen above a door to a government building.
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    Defibtech recalls chest compression device linked to patient death

    Customers are asked to return affected devices due to a problem in the motor that could stop compressions.

  • A Roche logo is seen on the side of a building.
    Image attribution tooltip
    Courtesy of Roche
    Image attribution tooltip

    Roche to increase global laboratory capacity for mpox testing

    The World Health Organization has declared an mpox outbreak to be a public health emergency of international concern.

  • A picture of Getinge's headquarters building in Gothenburg, Sweden.
    Image attribution tooltip
    Courtesy of Getinge
    Image attribution tooltip

    Getinge to buy Paragonix organ-preserving tech for up to $477M

    Getinge will pay $253 million in cash at closing, with additional payments expected to be made between 2024 and 2026 if certain milestones are met.

    M&A