Advancing Coronary Care: FDA Clearance and Expanded Access for Next Gen Heartflow Plaque Analysis

Since Heartflow’s inception, our goal has been to empower clinicians with the clarity they need to confidently guide care and improve outcomes for patients living with coronary artery disease (CAD). Achieving that clarity requires both groundbreaking technology and collaboration across clinical, administrative and research teams. I’m proud to celebrate two recent milestones that reflect years of effort and innovation in bringing these capabilities to more patients and clinicians than ever before.

Our recently launched Next Gen Heartflow Plaque Analysis algorithm has received FDA 510(k) clearance and represents the culmination of years of development and clinical collaboration. Leveraging enhanced AI, this update marks the most advanced iteration of our technology to date.

Heartflow Plaque Analysis is the only FDA-cleared plaque quantification tool with a reported 95% agreement with the invasive gold standard, IVUS, using blinded core lab adjudication¹. Our technology provides clinicians with a color-coded, 3D view of plaque type, burden, and distribution. Trained on data from a growing database of more than 110 million coronary CTA images—the world’s largest—it delivers a 21% improvement in plaque detection compared to the first-generation algorithm². Our enhanced nomogram is based on data from more than 273,000 patients—nine times larger than any other current plaque quantification study³.

Our FDA clearance reflects the rigor and validation behind our work, as the exemplary Heartflow team leverages our data flywheel to continually improve our technology. I’m looking forward to seeing the rapid impact of Heartflow Plaque Analysis in enabling clinicians to see CAD with greater clarity, identify high-risk patients earlier, and make more accurate and informed decisions about care. 

Innovation is most powerful when it reaches the people who need it. That’s why Cigna’s recent decision to cover Next Gen Heartflow Plaque Analysis is also a significant step forward. This coverage builds on similar decisions by UnitedHealthcare, Medicare and other insurers to ensure that more patients nationwide can benefit from advanced insights powered by Heartflow, and that more clinicians can integrate these insights into their daily care. 

These milestones bring us closer to transforming CAD from the leading cause of death into a disease that can be managed for life. I am deeply grateful to our team and clinical partners, whose expertise and dedication continue to make this progress possible. Together, we are building a future where every patient receives the clearest possible picture of their heart health, and every clinician is equipped to deliver the best care.

See CAD. Manage for life.