FDA


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    Mercury Medical recalls emergency resuscitators

    Healthcare professionals use the devices to provide newborns and infants with emergency breathing support.

    By Oct. 8, 2024
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    Courtesy of Exact Sciences
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    Exact Sciences wins FDA approval for Cologuard Plus colorectal cancer test

    Exact Sciences expects to launch the updated test, which has higher specificity than its predecessor, with Medicare coverage and guideline inclusion in 2025.

    By Oct. 7, 2024
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    Trendline

    Medical device safety in spotlight after high profile recalls

    From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.

    By MedTech Dive staff
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    FG Trade via Getty Images
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    Elucid wins FDA 510(k) nod for heart plaque image analysis software

    The software turns coronary CT angiography images into 3D models that quantify and classify plaque morphology to improve predictions of heart attack and stroke risk.

    By Oct. 4, 2024
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    Permission granted by Becton Dickinson
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    BD agrees to settle most of its hernia mesh litigation

    The settlement terms are confidential, BD said. The company disputes the lawsuit’s allegations and backs its product designs.

    By Oct. 3, 2024
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    Jolygon via Getty Images
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    FDA authorizes Pi-Cardia’s valve-in-valve TAVR device

    Pi-Cardia designed the Shortcut device to mitigate the risk of coronary artery obstruction by splitting aortic valve leaflets before valve placement.

    By Oct. 3, 2024
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    Courtesy of Siemens Healthineers
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    Siemens Healthineers wins FDA approval for 3D mammography system

    The 3D capabilities are part of Siemens’ first completely redesigned mammography platform in over a decade.

    By Oct. 2, 2024
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    Stringer via Getty Images
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    GE Healthcare gets FDA nod for new PET imaging agent

    Called Flyrcado, the radiotracer could help improve cardiac imaging accuracy in patients with a high body mass index and women, the company said.

    By Oct. 1, 2024
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    Sarah Silbiger via Getty Images
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    Establishment Labs wins FDA approval for Motiva breast implants

    Motiva is the first new breast implant to receive premarket approval since 2013, according to Establishment Labs, and enters a market reshaped by safety issues linked to other products.

    By Sept. 30, 2024
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    Permission granted by Peyton Helbert / AAMI
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    Lawmakers call for investigation of former FDA device director

    The letter to the health department watchdog follows a New York Times report that raised concerns about Jeff Shuren’s potential conflicts of interest as head of the FDA’s device center.

    By Sept. 26, 2024
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    Sarah Silbiger via Getty Images
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    FDA proposes reclassifying hepatitis B assays

    The FDA plans to move the assays from higher-risk class III devices to class II, making them eligible for the 510(k) pathway.

    By Sept. 26, 2024
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    Permission granted by FDA
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    FDA names new head of medical device evaluation and quality

    Ross Segan was chosen to lead the office, which handles premarket authorizations and recalls, in the agency’s Center for Devices and Radiological Health.

    By Sept. 24, 2024
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    Sarah Silbiger via Getty Images
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    FDA posts draft guidance on biocompatibility testing of devices

    To promote consistency and reliability in premarket submissions, the FDA shared approaches for device biocompatibility analysis.

    By Sept. 23, 2024
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    Courtesy of GE Healthcare
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    GE Healthcare wins FDA clearance for Alzheimer’s imaging software

    The clearance adds a Centiloid scale tool to GE Healthcare’s Mim software to help clinicians determine the density of amyloid plaque.

    By Sept. 20, 2024
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    Advamed backs FDA’s misinformation draft, calls for updates on AI and deep fakes

    Advamed said the draft guidance “better reflects the wide scope of internet-based content seen in today’s information age” than an earlier version.

    By Sept. 16, 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 closes Silk Road Medical acquisition

    Completion of the purchase comes three months after the companies announced the deal, and after Boston Scientific resubmitted its merger filing to give the FTC more review time.

    By Updated Sept. 17, 2024
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    Scott Olson via Getty Images
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    Apple wins FDA nod for hearing aid software for certain Airpods

    Apple is the first company to receive authorization for over-the-counter hearing aid software.

    By Sept. 13, 2024
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    Sarah Silbiger via Getty Images
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    FDA warns 2 Chinese labs for oversight failures, animal care violations

    The FDA said the problems “raise concerns about the quality and integrity of data generated by the labs,” which provide third-party testing and validation data services for device firms.

    By Sept. 12, 2024
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    Permission granted by Abbott
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    Dexcom, Abbott OTC glucose sensors add to busy year for diabetes tech

    New over-the-counter sensors, an Abbott-Medtronic partnership and Roche’s first CGM are among diabetes technology’s top stories so far in 2024. Check out MedTech Dive’s roundup of the latest news.

    By Sept. 11, 2024
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    Sarah Silbiger via Getty Images
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    FDA to investigate presence of metals in tampons

    Members of the Democratic Women’s Caucus last week urged FDA Commissioner Robert Califf to address the safety concerns.

    By Sept. 11, 2024
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    Adene Sanchez via Getty Images
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    Lab group urges lawmakers to rescind FDA final rule on LDTs

    A survey found 48% of labs will discontinue LDTs if they do not qualify for an exception under the FDA final rule.

    By Sept. 9, 2024
  • FDA cracks down on ozone cleaners for CPAP machines

    The agency sent warning letters to four companies and reminded the public it has not authorized any devices for cleaning or disinfecting CPAPs.

    By Sept. 5, 2024
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    SDI Productions via Getty Images
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    European heart group recommends renal denervation for some patients

    The European Society of Cardiology said the treatment may be considered for certain patients with uncontrolled, drug-resistant high blood pressure but outlined lingering concerns.

    By Sept. 4, 2024
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    Courtesy of Grail
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    Illumina avoids fine for Grail purchase in European court victory

    Illumina will avoid a penalty of 432 million euros after a court ruled the European Commission did not have jurisdiction to challenge the company’s Grail acquisition.

    By Sept. 3, 2024
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    ARPA-H program to focus on AI degradation in medical tools

    The agency will fund work to identify and auto-correct AI-enabled tools that are misaligned with their underlying training data.

    By Sept. 3, 2024
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    Sarah Silbiger via Getty Images
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    FDA finalizes Voluntary Malfunction Summary Reporting guidance

    The agency clarified when companies can submit device malfunction reports in a quarterly summary, instead of individual reports every 30 days.

    By Aug. 30, 2024