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  • Becton Dickinson logo
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    Permission granted by Becton Dickinson
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    BD receives FDA warning letter over quality system violations

    Inspectors found 111 open tickets for software defects categorized as catastrophic or severe patient harm. Several safety complaints were also listed that BD didn’t report within the required timeframe.

  • A stethoscope rests on a pile of $100 bills.
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    Foremniakowski via Getty Images
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    Heart valve developer Anteris launches IPO

    IPOs in medtech have been sparse, but some analysts said improving market conditions could support a revival of offerings in 2025.

  • A circular device with a metal mesh around it.
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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.

    Updated Dec. 23, 2024
  • 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 updates cryoablation catheter instructions after 4 death reports

    The update followed a higher than expected number of reports of esophageal injury after catheter ablation procedures for atrial fibrillation.

  • A person in a blue suit speaks at a podium in front of a sign reading "White House Conference on Women's Health Research."
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    Andrew Harnik via Getty Images
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    ‘Research that’s desperately needed’: White House conference spotlights women’s health

    “Sometimes the most under-hyped sectors are the best places to build very large businesses,” said one venture investor who attended the Dec. 11 event.

  • Merit Medical President Joseph Wright wears a light blue shirt, gray jacket and glasses in a headshot.
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    Retrieved from Merit Medical on December 17, 2024
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    Merit Medical president to resign after unspecified conduct allegations

    Joseph Wright’s resignation is effective in January, and CEO and founder Fred Lampropoulos has been reappointed president.

  • A person digs with a spade in a raised garden bed.
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    Courtesy of Dexcom
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    Dexcom adds generative AI to over-the-counter CGMs

    Dexcom this week began rolling out the feature, which analyzes data to provide personalized tips and recommendations.

  • 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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    Namandjé Bumpus, FDA’s No. 2 official, to depart agency at end of year

    Bumpus replaced agency veteran Janet Woodcock as principal deputy commissioner in February 2024. She was previously the FDA’s chief scientist.

    FDA
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    Permission granted by Becton Dickinson
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    BD to pay $175M to settle charges of misleading investors on Alaris pump

    BD will pay a civil penalty to resolve charges it misled investors about risks associated with sales of its Alaris infusion pump, the Securities and Exchange Commission said.

  • A picture of the lobby of Boston Scientific's corporate China reception.
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    Courtesy of Boston Scientific
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    Boston Scientific recalls Accolade pacemakers tied to 2 deaths

    Certain Accolade pacemakers can permanently enter safety mode, which limits the devices’ ability to treat patients properly and requires early replacement.

  • Food And Drug Administration Headquarters In Maryland
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    Sarah Silbiger via Getty Images
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    Q&A

    CDRH cyber official on compliance with new rules, ongoing security threats

    Nastassia Tamari discussed compliance with new device cybersecurity requirements, the risks of legacy devices and frequent cyberattacks in healthcare.

    Updated Dec. 17, 2024
    FDA
  • Medtronic's Affera all-in-one ablation system
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    Courtesy of Medtronic
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    PFA to surpass radiofrequency ablation in 2025: Citi survey

    Pulsed field ablation could soon be used in the majority of electrophysiology procedures to treat atrial fibrillation as Medtronic, Boston Scientific and Johnson & Johnson battle for market share.

  • Professional photo of Ivan Tornos
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    Permission granted by Zimmer Biomet
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    Zimmer receives FDA nod for stemless shoulder implant

    The Osseofit devices are intended to match patients’ shoulder bone anatomy and preserve healthy bone in total shoulder replacement procedures.

  • Professional photo of Paul Ziegler standing in front of a window.
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    Permission granted by Augmedics
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    Augmedics names Paul Ziegler as CEO

    Augmedics sells an augmented reality headset that allows spine surgeons to view virtual images of the patient’s bones and surgical instruments inside the body. Ziegler is the former CEO of Viewray.

  • A square device with a screen has a clear container with a tube.
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    Courtesy of Fresenius
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    FDA issues first early alert with Fresenius Kabi infusion pump recall

    Fresenius Kabi is asking hospitals to remove certain pumps because of the risk of an alarm that could interrupt treatment.

  • A closeup of surgical instruments on Endoquest's robotic system.
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    Permission granted by Endoquest Robotics
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    Endoquest robotic system gets FDA OK to launch clinical trial

    A pivotal study of the robotic platform in colorectal surgery will begin at five hospitals in early 2025.

  • In this photo illustration, the welcome screen for the OpenAI "ChatGPT" app is displayed on a laptop screen on February 03, 2023 in London, England.
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    Leon Neal / Staff via Getty Images
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    4 takeaways from the FDA’s first digital health advisory committee

    Industry and patient representatives debated how the FDA should regulate generative AI in medical devices and address new challenges with the technology, such as the use of complex models that can change quickly.

  • Capstan employee Evelyn Haynes is wearing blue gloves while working on the company's heart valve device.
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    Permission granted by Capstan Medical
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    Capstan Medical raises $110M for heart valve with robotic system

    The startup’s third round of financing includes support from Intuitive Surgical’s venture capital arm.

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    Justin Sullivan via Getty Images
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    Labcorp closes takeover of Ballad Health outreach laboratory services

    Labcorp continued its streak of hospital lab purchases with a deal that will expand its testing capabilities to communities in Tennessee, Virginia, North Carolina and Kentucky.

    M&A
  • A person sits in a chair while another person examines their teeth.
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    skynesher via Getty Images
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    Patterson, a dental products distributor, agrees to $4.1B sale to healthcare investor

    Last week, Patterson Companies announced it would seek strategic alternatives after the company’s profit decreased by one-third in its fiscal second quarter.

  • A picture of Masimo's headquarters building.
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    Mario Tama / Staff via Getty Images
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    Masimo lays off 75 employees in California

    Under new leadership, the patient monitoring company is allocating resources to fewer projects as it focuses on market opportunities that address unmet needs, a spokesperson said.

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    JuSun via Getty Images
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    Artivion says cybersecurity incident has disrupted order, shipping processes

    The heart device manufacturer has taken certain systems offline in response to the incident, which involved the acquisition and encryption of files.

  • Trump pointing in front of a row of American flags
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    Chip Somodevilla via Getty Images
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    How Trump’s second term will affect the medtech industry

    From M&A and tariffs to new health leaders, here are the top issues for the medtech industry to watch when President-elect Donald Trump returns to office.