Heartflow's AI for Coronary Plaque Analysis Receives FDA Clearance and Expanded Insurance Coverage

Heartflow, a leading medical technology company, has achieved significant milestones in the development and commercialization of its artificial intelligence (AI) platform for coronary plaque analysis. The company's latest advancements include FDA clearance for an updated version of its AI software and expanded insurance coverage, marking important steps forward in cardiovascular diagnostics and patient care.

FDA Clearance for Next-Generation AI Platform

Heartflow has secured FDA clearance for the next generation of its AI-powered coronary plaque analysis platform. This advanced software offers enhanced capabilities for analyzing the buildup of dangerous plaques within coronary arteries, providing clinicians with valuable insights for patient management.

The updated platform features 3D, color-coded visualizations that quantify plaque blockages based on their type, volume, and distribution throughout the vessels. According to Heartflow, studies have shown that its AI aligns with standard intravascular ultrasound imaging 95% of the time, demonstrating high accuracy in plaque detection and characterization.

Notably, the new algorithm has improved plaque detection by 21% compared to its previous version. This advancement is based on Heartflow's extensive dataset, which includes CT angiography scans from approximately 273,000 individuals.

Expanded Insurance Coverage and Clinical Impact

In a significant development for patient access, Cigna has announced that it will cover Heartflow's plaque analysis software across its commercial and Medicare Advantage plans, effective October 1, 2025. This decision follows UnitedHealthcare's coverage determination in July, marking the second major private insurer to offer coverage for the technology.

The expanded insurance coverage comes on the heels of Heartflow's platform obtaining a category I CPT code, which is set to take effect in January 2026. This coding update is expected to further streamline reimbursement processes and increase accessibility for patients.

Heartflow's registry data has demonstrated the clinical impact of its AI-powered analyses. The company reports that personalized readouts have led to changes in treatment approaches for more than half of examined patients, underscoring the technology's potential to influence clinical decision-making and improve patient outcomes.

Future Developments and Market Position

Looking ahead, Heartflow has announced plans to expand its product offerings. The company intends to roll out 3D planning software for percutaneous coronary intervention procedures, including tools for stent placement and other revascularization strategies. This expansion aims to provide clinicians with comprehensive solutions for both diagnostic and interventional cardiology.

Heartflow's recent developments come after a successful initial public offering (IPO) on the Nasdaq, which raised approximately $364 million. The company's strong market position and ongoing innovation in cardiovascular AI technology continue to solidify its role as a key player in the medical technology sector.

John Farquhar, CEO of Heartflow, emphasized the clinical value of their technology, stating, "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."