NewYork-Presbyterian, Columbia Researchers Secure FDA Clearance for AI Heart Screening Tool

Researchers at NewYork-Presbyterian and Columbia University Irving Medical Center developed EchoNext, a screening technology that received FDA clearance on June 23, 2026, according to digital health startup Pathway Labs. The tool analyzes standard 12-lead ECGs to identify structural cardiac abnormalities before patients display outward symptoms.

Dr. Pierre Elias, founder and CEO of Pathway Labs and medical director for artificial intelligence at NewYork-Presbyterian, said, "We have colonoscopies, we have mammograms, but we have not had equivalents for most forms of heart disease.”

“Through EchoNext, we are able to diagnose critical, high-risk conditions that the human eye can’t, and potentially deliver lifesaving treatment earlier.” Dr Elias added.

A First of Its Kind Case

The model was trained on more than 700,000 ECG-echocardiogram pairs across NewYork-Presbyterian's healthcare system, according to the company. In validation studies representing more than 20 hospitals and 500,000 patients across the United States and Canada, EchoNext reportedly identified structural heart disease more accurately than cardiologists, including cardiologists using AI assistance.