Cardiovascular AI software developer HeartFlow has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its Next Gen Heartflow Plaque Analysis algorithm.
The algorithm has shown a 21% improvement in plaque detection compared to the first-generation algorithm, the company noted. It now includes new features such as an enhanced nomogram consisting of data from nearly 275,000 patients, and advanced 3D color-coded visualization of plaque type, volume, and distribution.
Corresponding with the FDA clearance, the company also highlighted the unveiling of its DECIDE Registry of real-world data, as well as a Cigna coverage decision that becomes effective October 1 for Cigna patients with acute or stable chest pain and mild-to-moderate narrowing of coronary arteries (1% to 69% stenosis) identified on coronary CTA.
