Pathway Labs has publicly launched EchoNext, the world's first FDA-cleared AI tool that reads standard 12-lead electrocardiograms to flag structural heart disease, the New York startup announced June 23. Cleared for six indications, the model detects conditions that clinicians routinely miss, including right and left-sided heart failure, valve disease, severe hypertrophy compatible with infiltrative cardiomyopathy, and pulmonary hypertension.
Trained on 700,000 ECG-Echo Pairs
EchoNext was developed by researchers from Columbia University and NewYork-Presbyterian, where founder and CEO Dr. Pierre Elias serves as medical director for artificial intelligence. Trained on more than 700,000 paired ECGs and echocardiograms, the model identified structural heart disease more accurately than cardiologists in head-to-head testing, finding 77% of structural heart problems versus 64% for physicians, and has been validated across studies spanning more than 20 hospitals and 500,000 patients in the United States and Canada.
"While we have mammograms and colonoscopies for cancer, we have never had an equivalent form of early detection for the most common cause of death in the world — heart disease," Elias said. On June 22, Nature Medicine published the first peer-reviewed case in which AI detection of undiagnosed heart failure by EchoNext ultimately led to a heart transplant.
Distribution Through OpenEvidence
Pathway Labs is pairing the clearance with a partnership with OpenEvidence, the clinical decision platform used by more than 500,000 US physicians, letting doctors upload an ECG image and receive an algorithmic prediction of structural heart disease at the point of care. "FDA-approved AI shouldn't sit siloed in the ivory tower while patients wait years for it to reach them," said OpenEvidence chief medical officer Travis Zack.
Seed Capital to Scale Deployment
Alongside the launch, Pathway Labs announced an $8.5 million seed round led by AlleyCorp and Breyer Capital to expand deployment across health systems. The clearance extends a run of AI moving deeper into clinical screening, from 60-second full-body ultrasound scanners to multi-model surgical AI platforms and autonomous robotic pharmacies.
Reporting based on coverage from Business Wire and STAT News.