02/17/26 - HeartBeam ECG Synthesis Clearance, LEX VELO CLIA Waiver, FDA Digital Health Boundary Updates, Disc Medicine CRL

This episode examines HeartBeam’s FDA clearance for twelve lead ECG synthesis software following appeal, LEX Diagnostics’ CLIA waived respiratory PCR platform, updated FDA guidance clarifying regulatory boundaries for AI enabled clinical decision support and wellness devices, CStone Pharmaceuticals’ IND clearance for CS2009 trispecific antibody trials across fifteen cohorts, Medtronic’s Stealth AXiS spine robotics platform approval with LiveAlign segmental tracking, and the Complete Response Letter issued to Disc Medicine for bitopertin in erythropoietic protoporphyria based on biomarker to clinical endpoint correlation gaps. The briefing covers regulatory pathway divergence across point of care diagnostics, digital health classification frameworks, oncology trial design, and surgical infrastructure consolidation.