Heartflow has secured a new FDA clearance for its artificial intelligence program to analyze the buildup of dangerous plaques within the heart’s coronary arteries.
Described as the next generation of its platform, the software offers 3D, color-coded visualizations that quantify plaque blockages based on their type, volume and distribution through the vessels.
According to the company, studies of its AI—which processes CT angiography scans and simulates the flow of blood—have shown it lines up 95% of the time with standard intravascular ultrasound imaging. At the same time, Heartflow said the updated algorithm has improved plaque detection 21% over its previous version.
Separately, the company’s registry data have demonstrated that personalized readouts have led to changes in treatment approaches among more than half of examined patients. Heartflow said its AI has been trained on scans collected from about 273,000 people.
“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,” CEO John Farquhar said in a statement. “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.”
At the same time, Heartflow announced that Cigna has opted to cover its plaque analysis software across its commercial and Medicare Advantage plans, starting Oct. 1. That marks the second major private insurer to offer coverage, following UnitedHealthcare’s decision in July. The platform previously obtained a category I CPT code, set to take effect in January 2026.
The former Fierce Medtech Fierce 15 winner also went public this past summer in a major Nasdaq IPO that raised about $364 million. Looking ahead, Heartflow said it plans to roll out 3D planning software for percutaneous coronary intervention procedures, including the placement of stents and other revascularization strategies.