HeartFlow Cleared by FDA; Cigna Coverage Oct. 1

HeartFlow received FDA 510(k) clearance for its Next Gen HeartFlow Plaque Analysis algorithm and platform, which is now available to clinicians. Built on a dataset of roughly 273,000 patients, the AI-powered tool includes updated algorithms, an expanded nomogram and advanced 3D color‑coded visualization, and reports about 95% agreement with intravascular ultrasound (IVUS) plus a 21% improvement in plaque detection versus the prior version. HeartFlow cited DECIDE registry findings showing the platform changed medical management for over 50% of patients beyond coronary CTA and is associated with an expected 15% reduction in events. Cigna will provide nationwide coverage effective October 1, 2025, joining UnitedHealthcare, for eligible patients with acute or stable chest pain and mild-to-moderate coronary stenosis. Market and trading outlets reported the clearance as market-moving and HeartFlow shares rose on the announcement.