HeartFlow receives US FDA approval for Plaque and RoadMap analysis AI products

HeartFlow FFRCT

HeartFlow has received US Food and Drug Administration (FDA) 510(k) clearance on two new, AI-powered products: Plaque and RoadMap analysis.

With its expanded product portfolio, HeartFlow is the first and only company to provide non-invasive coronary artery anatomy (RoadMap analysis), physiology (HeartFlow FFRCT), and plaque information (Plaque analysis) based on cardiac computed tomography angiography (CCTA), the company said in a press release. These products enable physicians to gain a more comprehensive understanding of a patient’s coronary artery disease and are the most accurate approach to predict risk of a heart attack.

“The 510(k) clearance of our Plaque and RoadMap analyses 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,” said John Farquhar, president and chief executive officer, HeartFlow. “FFRCT has already been recognised by the recent ACC/AHA Chest Pain Guidelines and is poised to change the standard-of-care in patients. Plaque and RoadMap analyses, together with FFRCT, 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.”

HeartFlow’s Plaque analysis provdes 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.

RoadMap analysis enables CT readers to improve coronary artery disease diagnosis by providing visualisation and quantification of the location and severity of anatomic narrowings in the coronary arteries on every CCTA.

“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. Combining anatomy, physiology, and plaque morphology would be essential for personalised patient care,” said Jagat Narula (Mount Sinai Morningside Hospital, New York, USA).

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. HeartFlow’s latest technologies will play a vital role in improving cardiovascular patient care.


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