Heartflow, a leader in AI-powered coronary artery disease (CAD) solutions, announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Next Gen Heartflow Plaque Analysis algorithm. The platform, now commercially available, incorporates an updated algorithm, an extensively expanded nomogram, and advanced 3D color-coded visualization of plaque type, volume, and distribution. These enhancements empower clinicians with precise insights to make confident care decisions efficiently. In addition, Heartflow Plaque Analysis will now be covered by Cigna across all lines of business, including Commercial and Medicare Advantage plans, effective October 1, 2025.
Next-Generation AI Enables Detailed 3D Plaque Visualization
Heartflow Plaque Analysis remains the only FDA-cleared, AI-driven plaque quantification tool demonstrating a 95% agreement with intravascular ultrasound (IVUS) using blinded core lab adjudication.1 The updated algorithm shows a 21% improvement in plaque detection over the first-generation version, allowing clinicians to more accurately diagnose and manage CAD.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.”
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The latest Plaque Analysis update represents Heartflow’s most sophisticated AI-powered technology to date. It offers clinicians an intuitive, 3D visual representation of plaque types, enabling rapid assessment of CAD location and severity. The platform’s enhanced nomogram is derived from approximately 273,000 patient datasets nine times larger than any existing plaque quantification study.3
Cigna Expands Nationwide Coverage for Heartflow Plaque Analysis
Cigna becomes the second major national insurer to cover Heartflow Plaque Analysis, aligning with guidelines issued by radiology benefit manager EviCore, following UnitedHealthcare’s earlier adoption. Coverage will be available for patients presenting with acute or stable chest pain and mild-to-moderate coronary artery narrowing (1–69% stenosis) identified via 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,” said John Farquhar, President and CEO of Heartflow. “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.”
This advancement follows Heartflow’s recent DECIDE Registry findings, demonstrating that Heartflow Plaque Analysis led to changes in medical management for over 50% of patients beyond coronary CTA alone, resulting in an anticipated ~15% reduction in adverse cardiovascular events.4,5 Heartflow continues to redefine cardiovascular care by providing physicians and patients with accurate, comprehensive, and efficient tools for precision coronary assessment.