This episode examines the first federal regulatory pathway for generative AI in cardiovascular care through ARPA-H’s ADVOCATE program, which funds autonomous clinical agents designed for FDA authorization within thirty-nine months. The briefing covers OneMedNet’s role in supporting the first five ten k clearance using regulatory-grade multimodal datasets, analyzes the valuation discount applied to six recently public health tech companies trading below emerging cloud software multiples despite comparable profitability, and reviews the FDA’s new risk classification framework that separates information tools from diagnostic devices. The episode concludes with CMS Innovation Center pilots testing reimbursement models for AI-assisted diagnosis and remote patient monitoring.
