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In this week’s Pathways Picks: Notified bodies and other EU groups oppose expanded “well-established technology” exemptions; CMS opens coverage analysis for a novel CRT device; FDA plans more 510(k) exemptions; South Korea clarifies transitions for digital health product labeling under a new law; and more medtech policy updates.
On a panel at the annual Dublin Innovation Summit engaged stakeholders discuss the benefits and challenges of gathering deep data during the development and testing of therapies and diagnostics, specific to the gender of the patients who will benefit from the medical interventions.
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.