FDA

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    Q’Apel recalls clot removal device in response to FDA warning letter

    Rather than pursuing a new regulatory pathway, Q'Apel said it is discontinuing the recalled system “as part of its strategic shift toward newer technologies.”

    By • June 18, 2025
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    Zyno recalls infusion pumps over unvalidated software

    Customers have been asked to stop using the pumps and wait for someone to contact them about exchanging devices.

    By • June 17, 2025
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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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    Could the FDA take an indirect approach to regulate LDTs?

    Attorneys said many questions remain about LDT regulation after the FDA lost its legal fight. A recent warning letter could be a clue to future enforcement.

    By • June 16, 2025
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    Centerline recalls guidewire over risk of coating being left in patients

    Coating for the guidewires could come off and get left in patients, which could result in extended or additional procedures. No serious injuries or deaths have been tied to the recall.

    By • June 16, 2025
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    Medtronic recalls ventilators linked to 2 serious injuries, 1 death

    The recall comes more than one year after Medtronic announced it would exit the ventilator market.

    By • June 12, 2025
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    FDA schedules first public MDUFA VI meeting ahead of negotiations

    Officials want to know what current features should be reduced or stopped to “ensure the continued efficiency and effectiveness of the medical device review process.”

    By • June 11, 2025
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    Baxter recalls Novum pump linked to 1 serious injury

    The company has asked users to monitor patients frequently to ensure the appropriate infusion is being delivered.

    By • Updated June 11, 2025
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    HHS staffers sue over ‘hopelessly error-ridden’ layoffs

    Most of the 10,000 HHS employees let go this spring could qualify for the class, according to lawyers. It’s the latest in a string of litigation against the Trump administration for drastically downsizing the federal workforce.

    By Rebecca Pifer • June 5, 2025
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    Smiths Medical recalls infusion pumps over 3 problems

    Smiths has not reported any serious injuries or deaths related to the issues, but the FDA sees a risk of harm. 

    By • June 4, 2025
  • U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. testifies before the Senate Committee on Health, Education, Labor, and Pensions on Capitol Hill on May 14, 2025 in Washington, DC.
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    HHS releases more detailed 2026 budget disclosing scope of cuts

    On Friday, the HHS fleshed out a preliminary budget released in the spring and gave new details about which of its programs would be terminated if the Trump administration gets its way.

    By Rebecca Pifer • June 2, 2025
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    Bivacor wins FDA breakthrough nod for titanium total artificial heart

    The company has so far treated patients who were weeks or months away from a transplant, but the device is theoretically suitable for longer-term use.

    By • June 2, 2025
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    Courtesy of Boston Scientific
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    Boston Scientific ends TAVR sales; J&J shares Monarch robot data

    Boston Scientific said it would halt worldwide sales of its Acurate devices due to “increased clinical and regulatory requirements.”

    By • May 28, 2025
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    FDA finds Chinese lab copied or falsified data, endangering patients

    The FDA said the findings raise doubts about the reliability and viability of premarket submissions based on the company’s data.

    By • May 28, 2025
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    BD recalls esophagogastric tubes linked to 2 serious injuries, 1 death

    A problem when preparing the devices for use can delay diagnosis or treatment, leading BD to update its instructions.

    By • May 27, 2025
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    Stryker wins FDA clearance for minimally invasive back pain treatment

    The company will compete with a device Boston Scientific acquired for $850 million.

    By • May 22, 2025
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    FDA sets stricter approval standards for COVID vaccines

    The agency will now require randomized, controlled data before approving new COVID shots for healthy children and adults, Commissioner Martin Makary and top vaccine official Vinay Prasad wrote in NEJM.

    By Delilah Alvarado • May 20, 2025
  • The headquarters of the FDA, which has recently issued a recall for Teleflex air filters used in hospital respirators.
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    FDA clears first blood test to aid Alzheimer’s diagnosis

    The FDA cleared the test for the early detection of amyloid plaques associated with Alzheimer’s in people aged 55 years and older with signs and symptoms of the disease.

    By • May 19, 2025
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    Retrieved from Teal Health on May 13, 2025
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    Teal wins FDA approval for at-home cervical cancer screening device

    The company plans to start shipping the device in June, starting in California and then expanding nationwide.

    By • May 13, 2025
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    FDA, aiming to speed scientific reviews, names chief AI officer

    Commissioner Martin Makary also said the agency would roll out a generative AI system across its centers that will help FDA scientists spend less time on repetitive tasks.

    By • May 9, 2025
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    AdvaMed calls for ‘zero for zero’ medtech tariffs between US and UK

    AdvaMed and its British counterpart called for urgent action to ensure the situation “does not devolve into a crisis.”

    By • May 7, 2025
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    HHS overhaul

    State attorneys general sue over ‘unconstitutional’ HHS restructuring

    The lawsuit alleges the Trump administration overstepped its authority in reshaping the federal health department and asked the court to reinstate workers laid off last month.

    By Susanna Vogel • May 7, 2025
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    HHS overhaul

    RFK’s FDA layoffs could slow safety communications, experts warn

    The mass cuts, which included communications staff, could slow public notices on medical device recalls and other safety alerts.

    By • May 6, 2025
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    Courtesy of Edwards Lifesciences
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    Edwards gains expanded TAVR label for asymptomatic patients

    The medical technology company expects the new indication to increase sales in its transcatheter aortic valve replacement business with more patients becoming eligible for the treatment.

    By • May 5, 2025
  • U.S. President Donald Trump watches as Health and Human Services Secretary Robert F. Kennedy Jr. (C) swears in Dr. Mehmet Oz (R) as the Medicare and Medicaid Services Administrator during a ceremony in the Oval Office at the White House on April 18, 2025 in Washington, DC.
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    Tracker

    Trump policies are upending healthcare. Track the effect on the medtech industry here.

    The FDA has rolled out an AI tool agency-wide, while a proposed HHS budget shows large cuts for the National Institutes of Health.

    By MedTech Dive Staff • Updated June 6, 2025
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    Medtronic wins FDA approval for defibrillation lead

    Omniasecure, which was authorized for placement in the heart’s right ventricle, is the world’s smallest defibrillation lead, according to Medtronic.

    By • Updated May 5, 2025