The Latest

  • Two docotors in a hospital room looking at an image of a patient's burned arm.
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    Retrieved from Spectral AI on March 18, 2025
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    Spectral AI algorithms beat physicians in burn tissue assessments

    The company plans to file the results with the FDA by mid-2025 and launch the product in 2026.

  • A sign for the FDA is displayed outside the agency's headquarters in Silver Spring, Maryland.
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    Sarah Silbiger via Getty Images
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    Top device firms report safety data late: BMJ

    BD, Medtronic and Abbott were among the top 10 device companies with the highest number of late reports to the FDA, the study found.

  • Tariff uncertainty sparks manufacturing anxiety, especially among small firms

    Shifting foreign suppliers could become more difficult as the Trump administration continues to enact new widespread tariff policies.

  • Four robots side by side with a single arm have different instruments attached to the end.
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    Courtesy of Stryker
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    4 takeaways from AAOS 2025

    Stryker unveiled its updated Mako surgical robot and orthopedic companies expect procedure volumes to remain steady despite recession fears.

  • Food And Drug Administration Headquarters In Maryland
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    Sarah Silbiger via Getty Images
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    FDA adds hemodialysis devices to shortage list amid B. Braun disruption

    The disruption is expected to impact patient care, may require adjustments to the management of hemodialysis patients and could continue through the early fall of 2025.

  • A picture of Mehemet Oz sitting behind a table in a Senate hearing room.
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    Anna Moneymaker/Getty Images via Getty Images
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    Dr. Oz stresses need for faster Medicare coverage of new devices during confirmation hearing

    Mehmet Oz, President Trump’s pick to lead the CMS, said Medicare beneficiaries should have quicker access to new medical devices once they’re FDA-approved.

  • Vicarious Surgical plans to seek de novo clearance for its surgical robot.
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    Permission granted by Vicarious Surgical
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    Vicarious Surgical appoints Sarah Romano as CFO

    Romano will arrive at the robotics company just as Chief Operating Officer John Mazzola is set to retire on April 1.

  • A 3D rendered image of a neural cell network, colored blue and set against a black background.
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    koto_feja via Getty Images
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    Vivani to spin off neurostimulation business

    The independent company will trade as Cortigent and advance brain implants to help people recover body functions such as vision and movement.

  • President Donald Trump addresses reporters during a press briefing at the White House on March 3, 2025.
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    Andrew Harnik via Getty Images
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    Deep Dive

    Healthcare tackles AI oversight with no aid from Trump administration

    The president’s deregulatory bent means more responsibility rests on the shoulders of healthcare stakeholders to get artificial intelligence right.

    AI
  • Lee Zeldin attends a press conference and squints into the sun.
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    Kevin Dietsch via Getty Images
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    EPA to reconsider emissions standards for medical device sterilizers

    Last year, the EPA issued a final rule that would limit emissions of ethylene oxide, a cancer-causing gas used to sterilize medical devices.

  • A flexible tube with a needle point is positioned in front of a hand holding a controller.
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    Retrieved from Screenshot: Johnson & Johnson on March 13, 2025
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    J&J’s Monarch robot wins FDA nod for AI software update

    Using Nvidia and GE Healthcare technology, the robotic surgery system is intended to help doctors detect lung cancer earlier.

  • A patient doing leg exercises guided by a smartphone using Hinge Health.
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    Courtesy of Hinge Health
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    Hinge Health, a virtual physical therapy firm, files for IPO

    The digital health IPO market has slowed to a crawl in recent years, but experts say it could be poised for a turnaround in 2025.

  • A technician performing tests at Labcorp
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    Courtesy of Labcorp
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    Labcorp to buy Opko unit’s cancer test assets for up to $225M

    Labcorp will acquire BioReference Health's oncology diagnostics operations as the lab company works to expand in high-growth testing areas.

    M&A
  • 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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    FDA accuses Mid-Link of copying or falsifying medical device test data

    The agency will reject all data from the Chinese service provider’s studies after Mid-Link failed to address concerns outlined in a warning letter last year, FDA officials said.

  • Capstan Medical's Dan Wallace and Maggie Nixon stand in a hallway.
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    Permission granted by Capstan Medical
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    Capstan brings surgical robot to valve replacement

    Capstan Medical, a startup focused on robotic-assisted mitral and tricuspid valve replacement, recently completed its first patient implants.

  • FDA headquarters sign
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    Stock via Getty Images
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    Douglas Kelly, deputy science director at FDA’s device center, leaves agency

    Kelly, who made several key hires at the CDRH and helped negotiate the last user fee agreement, announced his departure in a LinkedIn post Sunday.

    FDA
  • A female nurse operates a touch screen in a medical clinic.
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    Don Wu via Getty Images
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    ECRI warns insufficient AI governance threatens patient safety

    ECRI included other medtech-related threats on its list of patient safety concerns, noting that cybersecurity breaches can delay care and diagnostic errors can lead to improper treatment.

  • Close up of a person's hands with a pulse oximeter clipped on their pointer finger.
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    FG Trade via Getty Images
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    New FDA pulse oximetry guidelines could stall under Trump

    The draft guidance addresses criticisms that pulse oximeters are less accurate for people with dark skin tones. Experts raised concerns that it might not be finalized.

  • Image shows a spinal medical device.
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    Courtesy of Orthofix
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    Orthofix’s fired execs’ lewd, ‘graphic’ texts surface in legal battle

    Orthofix didn’t originally specify the reasons behind the 2023 firing of its CEO, CFO and CLO. Now, a court case is illuminating the story behind the terminations.

  • Dexcom's Stelo continuous glucose monitor.
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    Courtesy of Business Wire
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    Dexcom receives warning letter based on FDA inspections of 2 plants

    The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek clearance for new products.

  • A CDC sign on the agency's exterior building
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    Jessica McGowan/Getty Images via Getty Images
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    The top 3 impacts of Trump’s health data purge

    Interrupted access to health-related data has already led to worse outcomes and could undermine faith in the U.S. healthcare system, experts say.

    FDA
  • A closeup of an entryway that reads the Federal Trade Commission.
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    Stock via Getty Images
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    FTC challenges $627M private equity takeover of Surmodics

    The regulator said the buyout “would lead to a highly concentrated market for outsourced hydrophilic coatings and eliminate significant head-to-head competition.”

  • FDA administrator nominee Martin Makary speaks at a Senate confirmation hearing
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    Kayla Bartkowski via Getty Images
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    Following FDA cuts, Trump nominee Makary vows ‘independent’ staff review

    The Johns Hopkins surgeon highlighted rapid growth at the agency, but pledged key staff will have “all the resources they need to do their job well.”

    FDA
  • A person in a business suit speaks into a microphone.
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    Kayla Bartkowski via Getty Images
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    Makary, under review to run FDA, evades pressure to reinstate canceled vaccine meeting

    Questioned by senators at a Thursday hearing, President Donald Trump's FDA nominee said he would reevaluate which scientific topics require an advisory committee's input.

    FDA
  • A shipping container at the Port of Los Angeles on Sept. 20, 2024.
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    Mario Tama via Getty Images
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    Trump tariffs

    Illumina’s DNA sequencers hit with China import ban

    Illumina is not banned from operating in the country and will continue to serve its existing customers, a company spokesperson said.