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In this week’s Pathways Picks: The first EUDAMED registration requirements take effect this week, as some other important EU IVDR and MDR deadlines pass; Democratic lawmakers challenge medtech prior authorization pilot; FDA partially recognizes the recent revision to a key biocompatibility standard; and more global medtech policy updates.
MS has eliminated all orthopedic procedures from the inpatient-only rule, as of January 1, 2026—part of a three-year plan to remove the list entirely--and is working on other policy changes that expand access to lower-cost ambulatory surgery centers. Experts highlight how these changes will affect manufacturers’ commercial strategies and influence ASC procurement in ways that both incentivize and discourage adoption of high-cost technologies.
Senate Health chair loses primary and FDA AI chief departs. Excerpted from Pathways’ Picks May 21: Congress, FDA Exits, Notified Body Layoffs, CPT Codes, and More.