FDA Clears Next-Gen Heartflow Plaque Analysis Platform

Heartflow Inc. has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its next-generation Heartflow Plaque Analysis algorithm, which is now available for clinical use. The technology features an updated algorithm, vastly expanded nomogram, and advanced 3D color-coded visualization of plaque type, volume, and distribution, empowering clinicians with the insights needed to make confident care decisions with ease, according to the company.

Heartflow also announced that Heartflow Plaque Analysis is covered by Cigna (as of this month) across all its business lines, including commercial and Medicare Advantage plans.

Heartflow Plaque Analysis is the only FDA-cleared, artificial intelligence (AI)-powered plaque quantification tool with a reported 95% agreement with the gold standard, IVUS, using blinded core lab adjudication.¹ The latest algorithm advancement shows a 21% improvement in plaque detection compared to the first-generation algorithm, giving clinicians confidence in their CAD diagnosis and management.²

“Understanding not only how much plaque is present, but also plaque type and distribution, is critical in predicting patient risk and guiding personalized treatment,” said Matthew Budoff, M.D., professor of Medicine at the David Geffen School of Medicine at the University of California Los Angeles (UCLA) Medical Center. “With these enhanced capabilities, Heartflow Plaque Analysis provides clinicians with the clarity we need to move from detection to decision with speed and confidence.”

Leveraging enhanced AI, this new plaque analysis update marks the most sophisticated iteration of Heartflow’s technology, corporate bigwigs claim. It 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 roughly 273,000 patients—a dataset that is nine times larger than any current plaque quantification study.³

Cigna Coverage for Plaque Analysis

Cigna is the second national insurer to update its policies for Heartflow Plaque Analysis coverage to fully align with guidelines issued by radiology benefit manager EviCore, following a similar decision by UnitedHealthcare. The updated coverage took effect Oct. 1 for Cigna patients with acute or stable chest pain and mild-to-moderate coronary arteries (1% to 69% stenosis) identified on coronary CTA.

“Heartflow is proud to lead the way in coronary plaque analysis with our Next Gen platform, delivering the most representative visualization and context available for assessing patients’ disease and risk. Cigna’s decision to cover Heartflow Plaque Analysis is a testament to the power of our technology to positively impact care for its members across the United States,” Heartflow President/CEO John Farquhar stated. “Heartflow Analyses give clinicians a view of coronary plaque by type and impact on blood flow with FFRCT that’s key to informing management strategies. These latest advancements build on Heartflow’s record of proven innovation, leveraging clinical rigor and the world’s largest dataset of coronary CTA images to continually improve our technology for clinicians and patients.”

Heartflow’s continued advancement of plaque analysis technology follows the company’s recent unveiling of the landmark DECIDE Registry data, which showed Heartflow Plaque Analysis led to medical management change in more than 50% of patients beyond coronary computed tomography angiography (CTA) alone, resulting in an expected ~15% event reduction.^4,5 

Heartflow aims to transform 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 heart models, providing clinicians with actionable insights into plaque volume and composition and its impact on blood flow – without the need for invasive procedures. Supported by ACC/AHA guidelines and more than 600 peer-reviewed publications, Heartflow has helped clinicians manage nearly 500,000 patients worldwide.

References
¹ Ihdayhid A, et al. Radiol Cardiothorac Imaging. 2024. doi: 10.1148/ryct.230312 and internal bridging study with ICC correlation between first generation and second generation Plaque Analysis algorithm.
² U.S. Food and Drug Administration. 510(k) Premarket Notification: K250902. https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250902.pdf
³ Tzimas, et al., Presentation SCCT July 2025.
⁴ DECIDE Registry. Rinehart, et al., Presented at SCCT July 2025.
⁵ Collins et al. Lancet 2016. DOI: 10.1016/S0140-6736(16)31357-5