MOUNTAIN VIEW, Calif., Oct. 18, 2022 (GLOBE NEWSWIRE) — HeartFlow, Inc., the leader in revolutionary precision heart care, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for two new AI-enabled products: plaque analysis and timetable Analysis. With its expanded product portfolio, HeartFlow is the first and only company to offer non-invasive coronary artery anatomy (roadmap analysis), physiology (cardiac flow^(r) FFR_CT)and plaque information (plaque analysis) based on CCTA. These products give physicians a more complete understanding of a patient’s coronary artery disease (CAD) and are the most accurate approach to predict heart attack risk.¹

“The 510(k) approval of our plaque and RoadMap analyzes represents an important milestone in the company’s commitment to provide physicians with more comprehensive clinical insights to support the diagnosis and treatment of individual patients, wherever they are are on the coronary spectrum spectrum,” said John Farquhar, President and Chief Executive Officer, HeartFlow. “FFR_CT has already been recognized by the recent ACC/AHA guidelines for chest pain and is poised to transform the standard of care for patients. Plaque and RoadMap analyzes along with FFR_CTestablish HeartFlow’s platform technologies and will enable further development of AI-powered risk assessment to better identify asymptomatic patients at risk of heart attack.”

HeartFlow’s plaque analysis has been studied in more than 11,000 patients and will provide physicians with comprehensive and actionable data showing plaque characteristics and volumes in all major coronary arteries.² It allows physicians to conveniently provide important information about coronary plaque along with anatomy and physiology.³ Centers for Medicare & Medicaid Services recently announced that beginning October 1, 2022, plaque analysis will be reimbursed as a separate outpatient service.

RoadMap analysis enables CT readers to improve CAD diagnosis by…