The Latest

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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.

  Clinical Trials

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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.

  Medical Devices

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  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.

  Medical Devices

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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.

  Medical Devices

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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.

  Medical Devices

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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.

  Medical Devices

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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.

  Medical Devices

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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.

  Medical Devices

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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

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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.

  Medical Devices

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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.

  Medical Devices

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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.

  Digital Health

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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

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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.

  Medical Devices

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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.

  Clinical Trials

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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

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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.

  Digital Health

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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.

  Medical Devices

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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.

  Legal

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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.

  Medical Devices

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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

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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.”

  Legal

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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

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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

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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.

  Medical Devices