MOUNTAIN VIEW, Calif. — December 18, 2025 — Leads & Copy — Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), a leader in AI technology for coronary artery disease (CAD), announced that the American College of Cardiology (ACC) and the American Heart Association (AHA) have published new scientific statements supporting the prognostic value of quantifying coronary plaque and reinforcing the critical role of the coronary computed tomography angiography (CTA) + Heartflow pathway in CAD patient management.
The ACC’s consensus recommendations, published this week in JACC: Cardiovascular Imaging, highlight the importance of quantitative plaque assessment and underscore the benefits of adopting AI-powered Heartflow Plaque Analysis for personalized, precision cardiac care. The ACC statement elevates plaque analysis from an emerging technology to a defined clinical consideration in CAD management, outlining appropriate patient selection and best practices for interpreting and reporting.
Heartflow delivers a differentiated standard for clinical plaque quantification by combining AI-driven analysis with expert quality review, in direct alignment with the ACC’s call for rigorous quality assurance, reproducible results, and “human in the loop” analysis. Heartflow Plaque Analysis is the only FDA-cleared, AI-powered plaque quantification tool with 95% agreement to the gold standard, IVUS, using blinded core lab adjudication. This rigor, together with Heartflow’s commitment to standardized reporting and advanced algorithmic approaches such as adaptive thresholds, reflects a level of validation and quality oversight consistent with ACC guidance.
The AHA statement, published recently in Circulation, reinforces plaque burden and composition as central in managing nonobstructive CAD. The expert authors emphasize that patients with nonobstructive CAD should not be considered low-risk, recognizing that coronary plaque burden, extent, and composition are major determinants of outcomes. Earlier this year, a commission perspective published in The Lancet called for a fundamental shift in managing CAD, urging clinicians to focus on identifying and managing plaque early, before the opportunity for prevention has been lost.
According to Ron Blankstein, M.D., writing committee member for both the ACC and AHA statements, Director of Cardiac Computed Tomography at Brigham and Women’s Hospital, and Professor of Medicine and Radiology at Harvard Medical School, the ACC and AHA scientific statements address an important need by providing evidence-based consensus recommendations for clinicians and imagers, solidifying coronary CTA-based quantitative plaque analysis as a powerful tool for enhanced risk stratification in patients with suspected CAD. He adds that integrating AI-powered technology into clinical practice using ACC and AHA’s guidance can help clinicians move beyond diagnosing blockages, toward predicting and preventing major cardiovascular events.
Both the ACC and AHA scientific statements support the use of quantitative coronary plaque analysis to identify high-risk patients, enabling the immediate and appropriate initiation of preventive treatment. Heartflow Plaque Analysis addresses the need to quantify disease following visual detection of plaque, and is delivered instantly upon order to maintain seamless clinical integration and enable timely clinical decision-making.
According to Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer at Heartflow, the ACC and AHA scientific statements signal growing consensus that plaque assessment is essential for risk stratification, prevention, and long-term CAD management. He adds that Heartflow Plaque Analysis enables more precise risk stratification for personalized, preventive treatment plans.
The ACC and AHA’s scientific statements reflect a growing body of clinical evidence further substantiating the prognostic significance of Heartflow Plaque Analysis. A retrospective analysis of symptomatic patients from a cohort of the FISH&CHIPS Study presented at the AHA Scientific Sessions 2025 provided the largest validation to date of the Heartflow Plaque Staging framework based on total plaque volume measurement as a predictor of future heart attacks or cardiovascular death. The company is generating additional real-world evidence through the DECIDE registry, the largest prospective registry evaluating the clinical impact of Heartflow Plaque Analysis on medical management decisions. The DECIDE registry showed that more than 50% of patients had their medical management changed when Plaque Analysis with Plaque Staging* was added compared to their management based on CCTA alone.
Heartflow’s technology is redefining precision cardiovascular care through clinically-proven AI and the world’s largest coronary imaging dataset. Heartflow has been adopted by more than 1,400 institutions globally and continues to strengthen its commercial presence to make this cutting-edge solution more widely available to an increasingly diverse patient population. Backed by ACC/AHA guidelines and supported by more than 600 peer-reviewed publications, Heartflow has redefined how clinicians manage care for over 500,000 patients worldwide.
Heartflow meets or exceeds leading international standards, including HITRUST, SOC 2 Type 2, ISO 13485, and ISO 27001.
Heartflow is transforming coronary artery disease from the world’s leading cause of death into a condition that can be detected early, diagnosed accurately, and managed for life. The Heartflow One platform uses AI to turn coronary CTA images into personalized 3D models of the heart, providing clinically meaningful, actionable insights into plaque location, volume, and composition and its effect on blood flow — all without invasive procedures.
Media Contact:
Elliot Levy
elevy@heartflow.com
Investor Contact:
Nick Laudico
nlaudico@heartflow.com
Source: Heartflow, Inc.
