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HeartFlow Garners FDA Clearances for Two AI-Powered Assessment Tools with CCTA


Plaque Analysis and RoadMap Analysis, two artificial intelligence (AI)-enabled assessment products, may enhance clinical evaluation of coronary artery disease (CAD) on cardiac computed tomography angiography (CCTA).

The Food and Drug Administration (FDA) has granted 510(k) clearance to two emerging artificial intelligence (AI) tools that may improve the ability of clinicians to predict heart attack risk in asymptomatic patients.

HeartFlow’s Plaque Analysis, which offers quantitative assessment of plaque volume on cardiac computed tomography angiography (CCTA), has reportedly been studied in over 11,000 patients, according to the manufacturer.1 HeartFlow noted that earlier this month, the Centers for Medicare and Medicaid Services (CMS) started reimbursing plaque analysis as a separate outpatient service at hospitals.

HeartFlow said the recently FDA-cleared RoadMapAnalysis facilitates quick detection of stenoses in major coronary arteries on CCTA. In a recently published study, researchers said the AI-powered algorithm had superior reproducibility in comparison to intra-reader reproducibility in quantifying coronary stenosis.2

John Farquhar, the president and chief executive officer of HeartFlow, said the combination of Plaque Analysis and RoadMap Analysis with the company’s coronary physiology assessment tool HeartFlow FFRCT “ … will enable further development of AI-powered risk scoring to better identify asymptomatic patients at risk of heart attack.”

“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 personalized patient care,” noted Jagat Narula, M.D., Ph.D., the chief of cardiology at Mount Sinai Morningside Hospital.


1. GlobeNewswire. HeartFlow receives FDA 510(k) clearance for its Plaque analysis and RoadMap analysis. Available at: https://www.globenewswire.com/news-release/2022/10/18/2536623/0/en/HeartFlow-Receives-FDA-510-k-Clearance-for-its-Plaque-Analysis-and-RoadMap-Analysis.html . Published October 18, 2022. Accessed October 19, 2022.

2. Khasanova E, Indraratana P, Miranda P, et al. Head to head comparison reproducibility and inter-reader agreement of an AI based coronary stenosis algorithm vs level 3 readers. J Cardiovasc Comput Tomogr. 2022 May 5;S1934-5925(22)00068-5. Doi: 10.1016/j.jcct.2022.04.005. Online ahead of print.

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