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In this week’s Pathways Picks: Did FDA clear the first 510(k) for a large language model? South Korea advances its AI guidelines; India proposes accelerated review timelines; updates from Malaysia and China; Rep. Diana DeGette defeated; FDA signals end to COVID EUAs; TAP is open to all device types; Ireland ascends to Council presidency; and more global medtech policy news.
Today’s catheter-based system for urodynamic testing is often uncomfortable and painful, such that it’s almost a last resort, even though it’s the only tool clinicians have for accurately diagnosing and treating the causes of lower urinary tract symptoms. Urologic Health aims to burst that bottleneck with a new, noninvasive modality for urodynamic testing.
The first EUDAMED registration requirements took effect on May 28. Excerpted from Pathways’ Picks May 27: EU Milestones, Medtech Pilot Programs, FDA Biocomp Recognition.