Core Insights - Heartflow, Inc. has received FDA 510(k) clearance for its Next Gen Heartflow Plaque Analysis algorithm, which is now available for use [1][2] - Cigna will cover Heartflow Plaque Analysis across all its lines of business starting in October 2025, following similar coverage by UnitedHealthcare [1][4] Technology Advancements - The Heartflow Plaque Analysis is the only FDA-cleared AI-powered plaque quantification tool, showing a 95% agreement with the gold standard, IVUS [2] - The new algorithm demonstrates a 21% improvement in plaque detection compared to the first-generation algorithm, enhancing clinician confidence in diagnosing CAD [2][3] - The updated platform features advanced 3D color-coded visualization of plaque type, volume, and distribution, providing clinicians with critical insights for care decisions [1][3][13] Clinical Impact - The enhanced nomogram is based on data from approximately 273,000 patients, which is nine times larger than any current plaque quantification study [3] - Heartflow Plaque Analysis has led to medical management changes in over 50% of patients beyond coronary CTA alone, with an expected event reduction of around 15% [5] Industry Position - Heartflow is recognized as a leader in coronary plaque analysis, with a commitment to transforming the management of coronary artery disease [5][6] - The company has supported nearly 500,000 patients worldwide, leveraging clinical rigor and a vast dataset of coronary CTA images [6]

Core Insights - UnitedHealthcare has announced comprehensive coverage for Heartflow Plaque Analysis, marking a significant advancement in patient access to AI-driven technology for diagnosing and managing coronary artery disease (CAD) [1][2] - The coverage will be effective from October 1, 2025, specifically for patients with acute or stable chest pain and mild-to-moderate coronary artery narrowing [2] - Heartflow Plaque Analysis is the only FDA-cleared, AI-enabled, noninvasive plaque quantification tool, demonstrating a 95% agreement with the gold standard, IVUS [3] Coverage Details - The updated coverage includes all lines of business for UnitedHealthcare, such as Commercial, Medicare Advantage, and Community plans [1] - This decision aligns with guidelines from radiology benefit manager EviCore, enhancing the standard for cardiovascular care coverage [1][2] Clinical Impact - Management changes informed by Heartflow Plaque Analysis resulted in an average LDL cholesterol decrease of 18.7 mg/dL, which is associated with a 15% reduction in the risk of cardiac events [4] - The technology has been shown to change medical management in over half of patients beyond CCTA alone, improving clinical outcomes [3] Company Vision - Heartflow aims to transform CAD from a leading cause of death into a manageable condition, with CAD responsible for one heart attack every 40 seconds in the U.S. [5] - The company has been adopted by over 1,400 institutions globally, indicating a strong commercial presence and commitment to making advanced solutions widely available [5][6]