HeartFlow announced it has received FDA 510(k) clearance on two new noninvasive artificial intelligence-powered coronary artery anatomy and plaque analyses based on coronary CT angiography.
The new coronary artery anatomy (RoadMap) and plaque analyses provide physicians with comprehensive and actionable data on plaque characteristics and volume in all major coronary arteries, according to a company press release.
As of Oct. 1, CMS announced that the plaque analysis is paid as a separate service in the hospital outpatient department, according to the release.
The coronary artery anatomy analysis