Sept. 22, 2025 — Heartflow, Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Next Gen Heartflow Plaque Analysis algorithm and the platform is now available. Heartflow also announced that Heartflow Plaque Analysis will be covered by Cigna across all of its lines of business, including Commercial and Medicare Advantage plans, beginning in October. “With these enhanced capabilities, Heartflow Plaque Analysis provides clinicians with the clarity we need to move from detection to decision with speed and confidence.”Leveraging enhanced AI, this new Plaque Analysis update marks the most sophisticated iteration of Heartflow’s technology. “Heartflow is proud to lead the way in coronary plaque analysis with our Next Gen platform, delivering the most representative visualization and context available for assessing patients’ disease and risk. “Heartflow Analyses give clinicians a view of coronary plaque by type and impact on blood flow with FFRCT that’s key to informing management strategies.