Vendor source
Reviewed 16 Oct 2026
Completeness Strong (69%)
The HeartFlow Analysis is a coronary physiologic simulation software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides the calculations of FFRCT, a mathematically derived quantity, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. The HeartFlow Analysis is intended to support the functional evaluation of coronary artery disease.
Supported by 19 papers


General Information
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Regulatory Information
Pathway:
MDD
Class:
Class IIa
Verified by Health AI Register
Pathway:
510(k) cleared
Class:
Class II
Verified by Health AI Register
Other certifications
Not specified
Evidence & Research
Peer-Reviewed Papers
Developing a non-invasive diagnostic framework for the fractional flow reserve quantification in left coronary arteries: validation with patient cases
Frontiers in Physiology · Jul 2026
Coronary plaque burden and computed tomography-derived fractional flow reserve are predictors of 5-year mortality in peripheral artery disease patients with no known coronary artery disease
Journal of Vascular Surgery Cases, Innovations and Techniques · Jun 2026
Impact of an interactive CTCA/FFRCT interventional stent planning tool on patient management
The International Journal of Cardiovascular Imaging · Jul 2025
Implementation of a national AI technology program on cardiovascular outcomes and the health system
Nature Medicine · Apr 2025
Diagnosis and treatment of ischemia-producing coronary stenoses improves 5-year survival of patients undergoing major vascular surgery
Journal of Vascular Surgery · Mar 2024
Long-term prognostic implications of CT angiography-derived fractional flow reserve: Results from the DISCOVER-FLOW study
Journal of Cardiovascular Computed Tomography · Feb 2024
Computed tomography-derived fractional flow reserve (FFRCT) has no additional clinical impact over the anatomical Coronary Artery Disease - Reporting and Data System (CAD-RADS) in real-world elective healthcare of coronary artery disease
Clinical Radiology · Aug 2022
Impact of Fractional Flow Reserve Derived From Coronary Computed Tomography Angiography on Heart Team Treatment Decision-Making in Patients With Multivessel Coronary Artery Disease
Circulation: Cardiovascular Interventions · Dec 2019
1-Year Impact on Medical Practice and Clinical Outcomes of FFRCT
JACC: Cardiovascular Imaging · Mar 2019
Comparison of Coronary Computed Tomography Angiography, Fractional Flow Reserve, and Perfusion Imaging for Ischemia Diagnosis
Journal of the American College of Cardiology · Jan 2019
Coronary CT Angiographic and Flow Reserve-Guided Management of Patients With Stable Ischemic Heart Disease
Journal of the American College of Cardiology · Aug 2018
Real-world clinical utility and impact on clinical decision-making of coronary computed tomography angiography-derived fractional flow reserve: lessons from the ADVANCE Registry
European Heart Journal · Aug 2018
Identification of High-Risk Plaques Destined to Cause Acute Coronary Syndrome Using Coronary Computed Tomographic Angiography and Computational Fluid Dynamics
JACC: Cardiovascular Imaging · Mar 2018
Effect of the ratio of coronary arterial lumen volume to left ventricle myocardial mass derived from coronary CT angiography on fractional flow reserve
Journal of Cardiovascular Computed Tomography · Aug 2017
Computed tomography derived fractional flow reserve testing in stable patients with typical angina pectoris: influence on downstream rate of invasive coronary angiography
European Heart Journal - Cardiovascular Imaging · Mar 2017
1-Year Outcomes of FFRCT-Guided Care in Patients With Suspected Coronary Disease
Journal of the American College of Cardiology · Jul 2016
Quality-of-Life and Economic Outcomes of Assessing Fractional Flow Reserve With Computed Tomography Angiography
Journal of the American College of Cardiology · Oct 2015
Clinical outcomes of fractional flow reserve by computed tomographic angiography-guided diagnostic strategies vs. usual care in patients with suspected coronary artery disease: the prospective longitudinal trial of FFR<sub>CT</sub>: outcome and resource impacts study
European Heart Journal · Sep 2015
Diagnostic Performance of Noninvasive Fractional Flow Reserve Derived From Coronary Computed Tomography Angiography in Suspected Coronary Artery Disease
Journal of the American College of Cardiology · Jan 2014
Technical Specifications
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Source: Vendor | First published: Jun 9, 2024 | Last updated: Oct 16, 2026