The Latest

  • Freight trucks arrive at Pantaco Customs Complex in Mexico City with goods to be shipped to the U.S. The trucks are surrounded by piles of shipping containers.
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    Hector Vivas via Getty Images
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    Tariffs are paused for USMCA-compliant goods. How can companies qualify?

    Businesses that previously found pursuing USMCA treatment cost-prohibitive are scrambling to determine if they meet the trade deal’s requirements.

  • Monogram Technologies' robotic surgery system is displayed against a gray background.
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    Permission granted by Monogram Technologies
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    Monogram robot wins FDA OK; Vicarious hit by supplier woes

    Monogram Technologies secured 510(k) clearance for its robotic knee replacement system, while Vicarious Surgical blamed supply chain issues for delaying its regulatory timeline.

  • The exterior of Medtronic's Minnesota operational headquarters is shown along with its reflection in a pool of water.
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    Courtesy of Medtronic
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    Medtronic recalls embolization devices tied to 17 injuries, 4 deaths

    Medtronic will remove one model of Pipeline Vantage devices from where they’re used and sold and will update the instructions for another model.

  • Professional photo of Mark Field
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    Retrieved from Insulet on March 18, 2025
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    Insulet Chief Technology Officer Mark Field leaves

    Amit Guliani, group vice president of software engineering, was named acting chief technology officer, effective immediately.

  • 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.