Cardiovascular disease, the leading cause of deathTrusted Source 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 MedicineTrusted Source 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.