HeartFlow announced that the FDA granted 510(k) clearance to its AI-powered Plaque analysis and Roadmap Analysis products.
Mountain View, California-based HeartFlow designed its technology around coronary computed tomography angiography (CCTA). It now offers non-invasive coronary artery anatomy, physiology and plaque information based on CCTA.
The company said in a news release that it is the first to offer all three based on CCTA. RoadMap provides coronary artery anatomy. HeartFlow’s FFRCT offers physiology and Plaque analysis delivers plaque information. Altogether, these products enable physicians to gain a more comprehensive understanding of coronary artery disease (CAD). The company said they provide a way to accurately predict the risk of 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 CEO, HeartFlow. “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.”
About Plaque and RoadMap
Centers for Medicare & Medicaid Services announced that, as of Oct. 1, it offers plaque analysis as a separate service in the hospital outpatient department. The system enables the delivery of critical information regarding coronary plaque to physicians, along with anatomy and phyisology.
RoadMap enables CT readers to improve CAD diagnosis. It provides visualization and quantification of the location and severity of anatomic narrowing in the coronary arteries on every CCTA.
HeartFlow plans to begin real-world clinical use for Plaque and RoadMap analyses with select U.S. hospitals and health systems following the clearance.
“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,” said Dr. Jagat Narula, Chief of Cardiology at Mount Sinai Morningside Hospital. “Combining anatomy, physiology, and plaque morphology would be essential for personalized patient care.”