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]