Heartflow Gains FDA Clearance for Updated Plaque Analysis Algorithm

Heartflow has received 510(k) clearance for an updated version of its plaque analysis algorithm, which creates a personalized 3D model of a patient’s coronary arteries to assess the impact of plaque on blood flow. The improved algorithm demonstrates a 21% increase in plaque detection compared to the original version. Using AI, the technology analyzes coronary CT angiograms (CCTAs) to quantify plaque and support optimized treatment strategies, with registry data linking algorithm-guided interventions to LDL cholesterol reductions.

Alongside the clearance, Heartflow announced that Cigna will cover the product starting in October, following UnitedHealthcare. The updated algorithm also features 3D color-coded visualization of plaque type, volume, and distribution, leveraging data from 273,000 patients. With an estimated 5.5 million eligible patients, Heartflow views a potential $1.7 billion market opportunity and recently raised over $364 million in its IPO to support adoption and growth of the plaque analysis product.

25-09-2025