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In this week’s Pathways Picks: A proposal would allow firms to rely on EU MDR/IVDR CE marks indefinitely in Great Britain; notified bodies’ guide on IVD-instrument pairs; a EUDAMED snapshot; CMS announces insurer agreements and pay rates for its ACCESS digital health model; South Korea updates wellness product v. medical device policies; and more.
The Italian corporate venture firm doubled down on its commitment to CoMind this fall, indicating its global interest in connected health and in particular novel approaches to challenging problems in neurological conditions.
Agentic AI plans solicited to fill a cardiologist gap. Excerpted from Pathways’ Picks January 21: AI Cardiologist, Record-Setting FDA Approvals, EU Inspections Effort.