01/30/26 - FDA CDS Enforcement Discretion, Hardware-Agnostic Cardiac AI Clearances, CMS TEMPO Pre-Clearance Pilot

This episode examines FDA’s twenty twenty six Clinical Decision Support guidance updates addressing enforcement discretion for single-recommendation outputs and LLM summarization tools, new clearances for hardware-agnostic AI platforms detecting heart murmurs across multiple digital stethoscope brands, GE HealthCare’s automated PSMA imaging segmentation for prostate cancer burden analysis, and CMS’s TEMPO pilot program allowing pre-clearance prescribing of digital therapeutics tied to outcomes data collection within the ACCESS payment model. The briefing covers structural shifts in how regulatory pathways interact with reimbursement frameworks and vendor-independent AI deployment models.