The American College of Cardiology and the American Heart Association jointly released scientific statements endorsing HeartFlow’s Plaque Analysis tool as a core component of coronary artery disease management. The statements confirm the tool’s 95% agreement with intravascular ultrasound, its FDA clearance, and its ability to quantify plaque burden and composition from standard cardiac CT scans.
HeartFlow’s Plaque Analysis uses AI to generate a detailed plaque map from a routine coronary CT angiography. The 95% agreement with IVUS, verified by blinded core‑lab adjudication, demonstrates the tool’s accuracy and positions it as the only FDA‑cleared, AI‑powered plaque quantification platform in the market.
The endorsement signals that plaque assessment is a critical element of precision cardiac care. By formally recognizing the technology, the societies are likely to accelerate clinician adoption, strengthen reimbursement pathways, and expand the market for HeartFlow’s platform. The endorsement aligns with coverage from major insurers such as UnitedHealthcare and Cigna, further easing integration into routine practice.
HeartFlow’s Q3 2025 results showed revenue of $46.3 million, a 41% year‑over‑year increase, and a gross margin of 76.8%, up from 75.9% in Q3 2024. The company has guided full‑year 2025 revenue to $173 million–$173.5 million, reflecting confidence in continued demand for its AI‑driven diagnostic solutions.
Dr. Campbell Rogers, Chief Medical Officer, said the ACC and AHA statements confirm the growing consensus that plaque assessment is essential for risk stratification, prevention, and long‑term CAD management. Dr. Ron Blankstein, a writing committee member, noted that the statements solidify coronary CTA‑based quantitative plaque analysis as a powerful tool for enhanced risk stratification in patients with suspected CAD.
In a competitive landscape where AI‑driven diagnostics are rapidly expanding, the endorsement is a major strategic win for HeartFlow. It validates the company’s focus on early detection and accurate diagnosis, positions it as a leader in precision cardiovascular care, and sets the stage for future revenue growth as clinicians adopt the technology.
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