A routine electrocardiogram, the inexpensive test that records the electrical activity of the heart through 10 electrodes placed on the skin, has long been one of medicine's most common and most underutilized tools. A trained cardiologist reading an ECG can identify certain arrhythmias and ischemic patterns, but significant structural heart disease, including early-stage heart failure, valve disease, and dangerous thickening of the heart muscle, can be entirely invisible on a standard ECG review.
That changed on June 23, 2026, when the U.S. Food and Drug Administration cleared EchoNext, developed by Pathway Labs and researchers at NewYork-Presbyterian and Columbia University Irving Medical Center. The clearance covers six separate cardiac conditions detectable from a standard 12-lead ECG, making EchoNext the world's first FDA-cleared AI tool to screen for multiple forms of structural heart disease from a test already performed in millions of clinical encounters every year.
