HeartFlow’s Plaque Analysis and RoadMap Analysis Products Receive FDA Clearance

October 18, 2022—HeartFlow, Inc. announced it has received FDA 510(k) clearance for two artificial intelligence (AI)–powered products: the Plaque analysis and RoadMap analysis. With this FDA 510(k) clearance, HeartFlow will begin real-world clinical use of the Plaque and RoadMap analyses with select hospitals and health systems.

The company now provides noninvasive coronary artery anatomy (RoadMap analysis), physiology (HeartFlow FFRCT), and plaque information (Plaque analysis) based on coronary CTA (CCTA).

According to HeartFlow, Plaque analysis has been studied in more than 11,000 patients and will provide physicians with comprehensive and actionable data showing plaque characteristics and volume in all major coronary arteries. It enables critical information regarding coronary plaque to be delivered conveniently to physicians along with anatomy and physiology.

The company advised that the Centers for Medicare & Medicaid Services recently announced that, as of October 1, 2022, the plaque analysis is paid as a separate service in the hospital outpatient department.

The RoadMap analysis will enable CT readers to improve coronary artery disease diagnosis by providing visualization and quantification of the location and severity of anatomic narrowings in the coronary arteries on every CCTA. It has been shown to provide reproducible results and can help enable efficient, standardized, and high-quality CT interpretation, noted HeartFlow.

“It is exciting to note the work HeartFlow is doing to bring forward the innovative technologies to help us advance our understanding and care for patients with coronary artery disease,” commented Jagat Narula, MD, in the company’s press release. “Combining anatomy, physiology, and plaque morphology would be essential for personalized patient care.” Dr. Narula is Chief of Cardiology at Mount Sinai Morningside Hospital in New York, New York.