HeartFlow’s Two AI Tools Gain FDA Clearance

HeartFlow’s artificial intelligence (AI) based Plaque and RoadMap software tools for analysis of computed tomography (CT) angiography have received 510(k) clearance from the FDA for patients with coronary artery disease.

The Plaque software analyses physiology and plaque information while the RoadMap offers coronary artery anatomy details. Both tools are intended to aid in predicting the risk of a heart attack.

The Mountain View, Calif.-based company plans to offer the two AI-based tools for use in hospitals and health systems.