Heartflow’s Next-Generation Plaque Analysis Platform Cleared by FDA

September 22, 2025—Heartflow, Inc. announced it has received FDA 510(k) clearance for its next-generation Heartflow Plaque Analysis algorithm for the diagnosis and management of coronary artery disease (CAD). The platform is now available, noted the company.

Heartflow also announced that Heartflow Plaque Analysis will be covered by Cigna across all of its lines of business, including Commercial and Medicare Advantage plans, beginning in October.

According to the company, the technology features an updated algorithm, expanded nomogram, and advanced three-dimensional color-coded visualization of plaque type, volume, and distribution, providing clinicians with the insights needed to make care decision.

The company stated that Heartflow Plaque Analysis has reported 95% agreement with the gold standard of intravenous ultrasound, using blinded core lab adjudication. Additionally, the latest algorithm advancement has shown 21% improvement in plaque detection compared to the first-generation algorithm for confident diagnosis and management of CAD.

The new Plaque Analysis provides clinicians with an intuitive visual representation of plaque types, enabling rapid assessment of CAD location and severity. Heartflow’s enhanced nomogram is powered by data from approximately 273,000 patients, a dataset nine-times larger than any current plaque quantification study, stated the company.

In July 2025, Heartflow announced data from the landmark DECIDE Registry, which showed Heartflow Plaque Analysis led to a medical management change in > 50% of patients beyond coronary CT angiography alone, resulting in an expected event reduction of approximately 15%.

Finally, the company advised that Cigna is the second national insurer to update its policies to cover Heartflow Plaque Analysis to fully align with the guidelines issued by radiology benefit manager EviCore, after a similar decision by UnitedHealthcare. The updated coverage will become effective on October 1, 2025, for Cigna patients with acute or stable chest pain and mild-to-moderate narrowing of coronary arteries (1-69% stenosis) identified on coronary CT angiography, noted the Heartflow.