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The European Union’s AI Act retains device mandates. Excerpted from Pathways’ Picks May 13: Makary Exits FDA, EU AI Act Reforms Disappoint, UK Seeks Input, and More.
The first EUDAMED registration requirements took effect on May 28. Excerpted from Pathways’ Picks May 27: EU Milestones, Medtech Pilot Programs, FDA Biocomp Recognition.
Medicare’s phased-in elimination of the inpatient only rule and simultaneous expansion of the list of procedures it covers in ambulatory surgery centers are forcing medical device manufacturers to rethink where and how much they get paid.
The European Union’s AI Act retains device mandates. Excerpted from Pathways’ Picks May 13: Makary Exits FDA, EU AI Act Reforms Disappoint, UK Seeks Input, and More.