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In this week’s Pathways Picks: The EU finalizes tighter requirements for notified bodies, with compromises from an earlier proposal; Europe’s breakthrough device pilot launches; digital labeling initiative; UDI in EHRs; eSTAR clarifications; FDA upgrades AI and data tools; China trial exemptions; structured submissions in Canada; and more.
Three MTI cohort companies seek to add efficiency to various pain points in the practice of collecting medical images.
CMS advances novel payment models in orthopedics. Excerpted from Pathways’ Picks April 15: New Medicare Directions, AI Picks, and Global Regulatory Updates