FDA clears noninvasive AI-powered coronary anatomy, plaque analyzes

October 18, 2022

1 min read

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HeartFlow announced it has received FDA 510(k) clearance on two new noninvasive artificial intelligence-powered coronary artery anatomy and plaque analysis based on coronary CT angiography.

The new coronary artery anatomy (RoadMap) and plaque analyzes 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 provided visualization and quantification of the location and severity of the narrowing coronary arteries on CT angiography, aiding in CAD diagnosis, according to the release.

“The 510(k) clearance of our Plaque and RoadMap analyzes represents a major milestone in the company’s commitment to provide physicians with richer clinical insights to help diagnose and treat individual patients, no matter where they are on the coronary disease spectrum,” John Farquhar, president and CEO of HeartFlow, said in the release. “[CT-derived fractional flow reserve] has already been recognized by the recent [American College of Cardiology/American Heart Association] Chest Pain Guidelines and is poised to change the standard of care in patients. Plaque and RoadMap analyzes, together with [CT-derived fractional flow reserve]establish HeartFlow’s platform technologies and will enable further development of AI-powered risk scoring to better identify asymptomatic patients at risk of heart attack.”

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