The Latest
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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.
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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.
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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.
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Retrieved from Insulet on March 18, 2025
Insulet Chief Technology Officer Mark Field leaves
Amit Guliani, group vice president of software engineering, was named acting chief technology officer, effective immediately.
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Retrieved from Spectral AI on March 18, 2025
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.
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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.
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Courtesy of Nucor Steel Tuscaloosa.
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.
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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.
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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.
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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.
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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.