FDA clears next-generation platform for AI-powered heart assessments
Heartflow, the California-based medtech company that went public back in August, has received U.S. Food and Drug Administration (FDA) clearance for its new-look Plaque Analysis algorithm.
The FDA originally cleared Plaque Analysis in October 2022. It uses artificial intelligence (AI) to noninvasively review the coronary CT angiography (CCTA) results of present with coronary artery disease (CAD), highlighting any plaques found in the coronary arteries. This next-generation version of Plaque Analysis includes an updated algorithm, expanded nomogram and new 3D color-coded visualization capabilities.
The FDA reviewed new data on the effectiveness of Plaque Analysis when making its decision. According to that data, the updated platform is associated with a 21% improvement in plaque detection when compared to the previous version.
“Understanding not only how much plaque is present, but also plaque type and distribution, is critical in predicting patient risk and guiding personalized treatment,” Matthew Budoff, MD, professor of medicine at the David Geffen School of Medicine at the University of California Los Angeles Medical Center, said in a statement. “With these enhanced capabilities, Heartflow Plaque Analysis provides clinicians with the clarity we need to move from detection to decision with speed and confidence.”
“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,” added John Farquhar, Heartflow’s president and CEO.
An insurance update
As part of the same announcement, Heartflow revealed that Cigna will be covering the use of Plaque Analysis for all patients.
“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,” Farquhar said.
Heartflow rings the bell
Heartflow is riding a wave of momentum after officially going public in August. The company’s stock is now being traded on Nasdaq under the ticker symbol HTFL, and its members even celebrated by news by ringing the ceremonial opening bell.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.