Pathway Labs Announces World's First FDA Clearance for Multicondition AI in Cardiology and Partnership with OpenEvidence

Receiving FDA Approval for six types of heart disease, Pathway Labs’ EchoNext uses AI to flag high risk patients from electrocardiograms

NEW YORK--(BUSINESS WIRE)--Pathway Labs today announced its public launch of EchoNext, the world’s first FDA-approved AI detection tool that reads standard 12-lead electrocardiograms (ECGs) to flag high risk structural heart diseases for patients. Receiving FDA clearance for six indications, Pathway Labs also announced its partnership with OpenEvidence to make EchoNext available on the AI platform regularly used by over half of US clinicians. EchoNext detects heart conditions that clinicians cannot, including right and left-sided heart failure, valve disease, severe hypertrophy compatible with infiltrative cardiomyopathy, and pulmonary hypertension, enabling earlier detection of diseases that usually go undetected until a patient is already symptomatic. The model was trained on more than 700,000 ECG-echocardiogram pairs across NewYork-Presbyterian’s healthcare system and identified structural heart disease more accurately than cardiologists, including cardiologists using AI assistance. EchoNext has shown robust performance in a range of studies representing over 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,” said Dr. Pierre Elias, founder and CEO of Pathway Labs, as well as medical director for artificial intelligence at NewYork-Presbyterian and 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."

On June 22, 2026, Nature Medicine published a world-first case in which EchoNext detected undiagnosed heart failure otherwise missed that ultimately led to the world’s first heart transplant due to AI detection of disease. The case is the first peer-reviewed account of its kind.

A partnership with OpenEvidence to reach clinicians at scale

The partnership with OpenEvidence, the clinical decision platform that serves over 500,000 physicians nationwide, puts EchoNext's screening output in front of physicians using the tools they already turn to 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. Putting EchoNext on OpenEvidence means a breakthrough in heart disease detection is available everywhere care happens, from major hospitals to community practices," said Travis Zack, Chief Medical Officer of OpenEvidence.

Financing to put technology into practice

Alongside the launch and clearance, Pathway Labs is announcing an $8.5 million seed round led by AlleyCorp and Breyer Capital to expand deployment across health systems, grow its clinical and commercial teams, and support ongoing R&D.

"One of the most compelling opportunities in medical AI is uncovering clinically meaningful signals from data we already collect. 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. We're proud to partner with Pierre and the Pathway Labs team to bring this technology into everyday clinical care," said Dr. Morgan Cheatham, Partner and Head of Healthcare and Life Sciences at Breyer Capital.

Dr. Alexi Nazem, MD, General Partner at AlleyCorp, added “Pathway Labs is going to save and improve so many lives by diagnosing heart disease sooner and enabling more effective therapeutic intervention. This remarkable technology is pioneering a new type of medicine where AI enables unprecedented capabilities, detecting latent signals in standard diagnostic tests. AlleyCorp is thrilled to support these brilliant scientists and entrepreneurs as they break new ground.”

“As a second-time founder, I’ve seen how often great clinical innovation stalls at implementation,” said Rachel Katz, co-founder and Chief Operating Officer of Pathway Labs. “Our job with this capital is to get this into real workflows, across real health systems, at national scale.”

About Pathway Labs

Pathway Labs builds AI that helps clinicians catch heart disease earlier, starting with EchoNext, a screening tool that reads routine ECGs to identify patients who should go on to an echocardiogram. Started by Dr. Pierre Elias and a world-leading team of cardiac AI researchers from Columbia University Irving Medical Center and NewYork-Presbyterian, Pathway Labs is dedicated to bringing rigorously validated cardiovascular AI out of the research setting and into everyday clinical care to help patients live longer, healthier lives.