The Latest

  • EU antitrust enforcement, Apple, Meta, Alphabet
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    Sean Gallup via Getty Images
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    EMA creates advice portal for some high-risk medical devices

    The European Medicines Agency said the portal will enable consultations with medical device expert panels that can promote faster access to new technologies. 

  • A picture of Inspire Medical Systems' patient app and remote.
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    Courtesy of Inspire Medical Systems
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    Inspire Medical reveals DOJ civil investigation

    CEO Tim Herbert told investors the company received a civil investigative demand from the Department of Justice in January for information on marketing and reimbursement practices.

  • Close up of Scott Gottlieb wearing a suit and tie
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    Drew Angerer via Getty Images
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    Former FDA head Gottlieb calls for less regulation of certain AI tools

    Gottlieb, who led the agency during the first Trump presidency, supports a reversion to an earlier interpretation of the 21st Century Cures Act.

  • Outside of Mass General Brigham
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    Wirestock via Getty Images
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    Mass General Brigham to conduct largest layoffs in its history

    MGB said the layoffs were necessary to get ahead of an anticipated budget shortfall of $250 million over the next two years.

  • FDA headquarters with sign in foreground
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    Sarah Silbiger via Getty Images
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    FDA posts early alert about BD device linked to 30 injuries, 4 deaths

    The alert was posted one day after BD sent customers a letter warning about the risk of atherectomy catheters breaking.

  • People seen walking down Wall Street.
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    Spencer Platt via Getty Images
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    M&A and a separation take center stage in latest earnings season

    BD announced it would split from its biosciences and diagnostics unit, while Zimmer Biomet updated investors on its $1.1 billion buy of Paragon 28.

  • Side view portrait of doctor and patient talking in a clinic setting.
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    SeventyFour via Getty Images
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    Q&A

    Why health systems should be ‘clear-eyed’ about business goals for AI tools

    Caroline Pearson, the executive director of the Peterson Health Technology Institute, discusses the institute’s new task force studying the financial, efficiency and workforce effects of AI products.

    Q&A
  • A photo of Thermo Fisher's manufacturing facility in Plainville, Massachusetts.
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    Courtesy of Thermo Fisher Scientific
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    Thermo Fisher lays off another 300 workers in Massachusetts

    Job cuts in Cambridge and Plainville are the second workforce reduction planned for the facilities in the past three months.

  • Becton Dickinson logo
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    Permission granted by Becton Dickinson
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    BD plans split from life science business to fuel medtech investment

    CEO Tom Polen said BD will “double down on shifting our portfolio, both organically and inorganically through tuck-in M&A, into higher-growth, high-margin accretive growth spaces.”

  • A metal, rounded device says "Senza Omnia" and has two attached leads.
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    Courtesy of Nevro
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    Globus to buy Nevro for $250M

    Analysts said Nevro’s valuation was “inexpensive,” but the spinal cord stimulation business can benefit from Globus’ scale and orthopedic relationships.

  • Professional photo of Ivan Tornos
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    Permission granted by Zimmer Biomet
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    Zimmer touts ASC opportunity with Paragon 28 purchase

    With the $1.1 billion acquisition, Zimmer Biomet expects its sports medicine, extremities and trauma segment will outpace hips and knees.

  • A nurse is seen caring for a patient just out of view.
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    Brandon Bell / Staff via Getty Images
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    Trump tariffs

    AHA joins call for Trump to exempt devices from import tariffs

    Disruption to the supply of devices from China would curtail hospitals' ability to perform life-saving surgeries and protect patients and healthcare workers from contagion, the group warned.

  • Professional photo of Orleigh Bogle
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    Permission granted by Medtronic
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    Q&A

    Medtronic’s Orleigh Bogle on changing the culture of surgical training

    Bogle, Medtronic’s head of medical affairs for digital surgery, also discussed the company’s plans to train surgeons for its Hugo surgical robot.

  • Photo of Michael F. Mahoney, CEO of Boston Scientific.
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    Courtesy of Boston Scientific
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    Boston Scientific closes its year of PFA on a high note

    Farapulse, Boston Scientific’s pulsed field ablation product, fueled year-over-year growth of nearly 171% in the fourth quarter for the company’s electrophysiology group.

  • A truck drives past a row of containers on rail cars.
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    Mario Tama via Getty Images
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    Trump tariffs

    Illumina placed on China’s unreliable entity list

    Analysts said the move comes amid rising trade tensions with the U.S. and as Illumina faces stiff competition in China’s genome sequencing market.

  • Recruitment or leadership concept. People row with spotlight highlighted one - creative visualization of people challenge competition
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    Getty Images via Getty Images
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    Pulse Biosciences names new CFO, continuing string of C-suite changes

    Pulse, which named a new CEO last month, is pitching its pulsed field ablation technology as a way to shorten procedure times.

  • 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 recall of brain fluid drainage systems linked to 15 injuries

    The company will keep the systems on the market but is asking providers to check devices for visible cracks and return affected devices.

  • Robert F. Kennedy Jr. sits behind a desk in a Senate hearing room.
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    Win McNamee via Getty Images
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    RFK Jr. clears key hurdle on path to HHS secretary

    A key Senate committee voted to advance Robert F. Kennedy’s nomination even after some legislators raised concerns about his previous vaccine stances and confusion surrounding programs like Medicare and Medicaid.

  • Tractor-trailers emerge from under an overpass while traveling side by side in a city landscape of Detroit.
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    ChrisBoswell via Getty Images
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    Trump tariffs

    Advamed pushes for medical device exemption from Trump tariffs

    CEO Scott Whitaker said “an exemption was provided for most medical devices during President Trump’s first term with respect to the tariffs on China, and we are advocating for a similar approach.”

  • An overhead shot of large, industrial building.
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    Courtesy of GE Healthcare
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    GE Healthcare invests $138M to expand contrast media production at Ireland site

    The new facility will enable production of 25 million more patient doses per year by the end of 2027.

  • The Olympus U.S. headquarters building is shown against a clear blue sky.
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    Retrieved from Olympus on February 03, 2025
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    FDA labels recall of discontinued Olympus endoscope part as Class I

    The update comes about six weeks after an early alert flagged reports of 120 injuries and one death linked to reprocessing of the device.