FDA-cleared AI tool flags hidden heart disease from a standard ECG

A newly FDA-cleared artificial intelligence tool can detect structural heart disease from a routine 12-lead electrocardiogram (ECG), catching conditions that often go undiagnosed until a patient becomes symptomatic, according to Pathway Labs, the company behind the technology.

The tool, called EchoNext, received FDA clearance for six indications and is designed to flag right- and left-sided heart failure, valve disease, severe hypertrophy consistent with infiltrative cardiomyopathy, and pulmonary hypertension. Pathway Labs said the model was trained on more than 700,000 paired ECGs and echocardiograms collected across the NewYork-Presbyterian health system, and has since been validated in studies spanning more than 20 hospitals and 500,000 patients in the U.S. and Canada. In those studies, the company said EchoNext identified structural heart disease more accurately than cardiologists, including cardiologists who had AI assistance.

"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," Pierre Elias, MD, founder and CEO of Pathway Labs, said in a statement. Elias is also medical director for artificial intelligence at NewYork-Presbyterian and an assistant professor of medicine and biomedical informatics at Columbia University Vagelos College of Physicians and Surgeons. "Through EchoNext, we are able to detect high-risk conditions that the human eye can't and may otherwise be missed."

Pathway Labs pointed to a case published June 22 in Nature Medicine in which EchoNext detected previously undiagnosed heart failure that the company said ultimately led to what it described as the first heart transplant attributable to AI-based disease detection. The company called it the first peer-reviewed account of its kind.

Partnership puts the tool in front of clinicians at the point of care

Alongside the FDA clearance, Pathway Labs announced a partnership with OpenEvidence, the AI-powered clinical decision platform the company said is used regularly by more than half of U.S. clinicians. The arrangement places EchoNext's screening output directly inside a tool many physicians already use during patient visits, rather than requiring a separate workflow or system.

"FDA-approved AI shouldn't sit siloed in the ivory tower while patients wait years for it to reach them," Travis Zack, MD, chief medical officer of OpenEvidence, said in a statement. "Putting EchoNext on OpenEvidence means a breakthrough in heart disease detection is available everywhere care happens, from major hospitals to community practices."

Seed funding to support deployment

Pathway Labs also announced an $8.5 million seed round led by AlleyCorp and Breyer Capital. The company said the funding will go toward expanding deployment across health systems, growing its clinical and commercial teams, and continuing research and development.

"One of the most compelling opportunities in medical AI is uncovering clinically meaningful signals from data we already collect," Morgan Cheatham, DO, partner and head of healthcare and life sciences at Breyer Capital, said in a statement. "Pathway Labs is redefining what can be discerned from one of the most widely ordered tests in medicine, the ECG, to surface structural heart disease that is otherwise imperceptible to the human eye."

Alexi Nazem, MD, general partner at AlleyCorp, said the company's approach represents a new direction for diagnostics. "This remarkable technology is pioneering a new type of medicine where AI enables unprecedented capabilities, detecting latent signals in standard diagnostic tests," Nazem said.

Rachel Katz, co-founder and chief operating officer of Pathway Labs, said the funding is intended to move the technology from pilot programs into routine use. "As a second-time founder, I've seen how often great clinical innovation stalls at implementation," Katz said. "Our job with this capital is to get this into real workflows, across real health systems, at national scale."

Pathway Labs was founded by Elias along with a team of cardiac AI researchers from Columbia University Irving Medical Center and NewYork-Presbyterian. The company describes EchoNext as a screening tool meant to identify which patients should be referred on for a full echocardiogram, rather than a standalone diagnostic.

AI-ECG tools gaining traction in cardiology

EchoNext's clearance adds to a fast-growing field of AI tools designed to extract diagnostic signal from the ECG, a test that is inexpensive, noninvasive, and already part of routine care for millions of patients. Other AI-enabled ECG platforms have recently earned regulatory clearance or reimbursement support for detecting specific conditions, including hypertrophic cardiomyopathy and aortic stenosis, often years before those conditions would otherwise be caught through symptoms or imaging.

The broader trend reflects a shift in how clinicians think about screening for cardiovascular disease: rather than relying primarily on echocardiography after a patient becomes symptomatic, AI models are increasingly being used to mine existing ECG data for subtle patterns associated with structural and valvular heart disease. Proponents argue this approach could meaningfully expand access to early detection, particularly in primary care and community settings where echocardiography may not be readily available. At the same time, payment policy is starting to catch up with the technology; Medicare has already established reimbursement codes specifically for AI-powered ECG analysis, a step that could accelerate adoption as more tools move through the FDA pipeline.

As more of these tools reach the market, health systems and payers will likely continue to weigh how AI-flagged findings should be incorporated into existing referral and diagnostic pathways, and how performance should be validated across different patient populations before broader rollout.