FDA Clears AI Tool to Spot Cardiovascular Disease Risk Ahead of Symptoms

A first-of-its-kind AI tool was cleared by the FDA to detect underlying structural heart disease before symptoms present. ljubaphoto/Getty Images The FDA cleared the first artificial intelligence tool to detect hidden structural heart disease during routine ECGs. Echo Next is a heart screening designed to detect underlying disease before symptoms present. The new tool is credited with spotting severe, undiagnosed heart failure in a 45-year-old man who ultimately received a successful heart transplant. Cardiovascular disease, the leading cause of death globally, has not yet had an early-detection test — until now. On June 22, the Food and Drug Administration (FDA) cleared a new tool to detect heart disease early. EchoNext is an artificial intelligence tool that reads a standard electrocardiogram (ECG) and flags those at high risk for structural heart disease, according to its maker, Pathway Labs. The company said that it’s the first AI tool approved by the FDA to detect this kind of hidden heart disease from an electrocardiogram, and that the clearance covers six indications. In June, Nature Medicine published the first peer-reviewed case in which EchoNext flagged severe, undiagnosed heart failure in a 45-year-old patient who ultimately received a heart transplant. Larger trials are underway, and Pathway Labs has raised $8.5 million to expand into more health systems, according to the company. EchoNext was built by researchers at NewYork-Presbyterian and Columbia University, led by Pathway Labs’ founder and CEO Pierre Elias, MD, an assistant professor of Medicine in the Department of Biomedical Informatics at Columbia University Data Science Institute. “We don’t have a screening test for the most common cause of death in the world, which is most forms of cardiovascular disease,” Elias said in a video released by NewYork-Presbyterian. “So we asked ourselves, could we take a cheap and ubiquitous test, and using AI, turn it into a scre