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What You Should Know: 

– Heartflow, a leader in AI technology for coronary artery disease (CAD), has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Next Gen Heartflow Plaque Analysis algorithm and platform. 

– The technology features an updated algorithm, an expanded nomogram, and advanced 3D color-coded visualization of plaque, empowering clinicians with crucial insights for confident care decisions. In addition, Heartflow announced that Cigna will provide nationwide coverage for the platform starting in October.

Advanced Technology for Deeper Clinical Insights

The Next Gen Heartflow Plaque Analysis is the only FDA-cleared, AI-powered plaque quantification tool with a reported 95% agreement with the gold standard, IVUS. The new algorithm offers a 21% improvement in plaque detection compared to its predecessor, giving clinicians greater confidence in their diagnosis and management of CAD. The enhanced nomogram is built on a dataset of approximately 273,000 patients, which is nine times larger than any other plaque quantification study.

Cigna Expands Coverage Nationwide

Following a similar decision by UnitedHealthcare, Cigna is the second national insurer to update its policies to cover Heartflow Plaque Analysis. The new coverage will be effective starting October 1, 2025, for Cigna patients with acute or stable chest pain and mild-to-moderate narrowing of coronary arteries (1-69% stenosis). This decision is a testament to the technology’s potential to positively impact care for Cigna’s members across the country.

Heartflow’s continued advancement of plaque analysis technology follows the company’s recent unveiling of its landmark DECIDE Registry data, which showed that the platform led to a change in medical management for over 50% of patients beyond coronary CTA alone, resulting in an expected 15% event reduction.

“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.”