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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.
Breast cancer is highly manageable when caught early, yet clinicians still face challenges: patient stratification after screening isn’t precise enough, and surgical outcomes could be improved. We spoke with Clairity, Cairn Surgical, and Resilient Medical—innovators working to raise the standard of care for this disease that predominantly affects women.
Mitral annular calcification has emerged as a priority in cardiology, as evidence increasingly links the condition to heart failure risk and procedural complications during mitral valve interventions. Bunkerhill Health’s solution enables early, consistent, and scalable identification of the condition. Excerpted from our recent feature article, Attacking MAC.