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In this week’s Pathways Picks: The US Quality Management System Regulation takes effect, launching a new framework for FDA inspections and triggering other updates; the EU harmonizes more medtech standards; South Korea spotlights “innovative device” designations; India drafts another IVD guide; US funding bill extends telehealth payments; and more.
All the major electrophysiology competitors are developing pulsed field ablation technologies to make treatment of cardiac arrhythmia safer and efficient. PFA is rapidly growing the overall electrophysiology market and every company developing a PFA system insists theirs offers unique advantages.
Agentic AI plans solicited to fill a cardiologist gap. Excerpted from Pathways’ Picks January 21: AI Cardiologist, Record-Setting FDA Approvals, EU Inspections Effort.