Pathway Labs wins FDA clearance for 6-condition AI heart scan tool

Pathway Labs on Tuesday launched EchoNext, the first FDA-cleared artificial intelligence tool that reads standard 12-lead electrocardiograms to flag six types of structural heart disease — conditions that often go undetected until patients become symptomatic. The New York-based startup also partnered with OpenEvidence, a clinical decision platform used by more than 500,000 US physicians, to distribute the screening output at the point of care.

"We have mammograms and colonoscopies for cancer, but 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 chief executive officer of Pathway Labs, who also serves as medical director for artificial intelligence at NewYork-Presbyterian and assistant professor 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."

The model was trained on more than 700,000 ECG-echocardiogram pairs across NewYork-Presbyterian's health system and identified structural heart disease more accurately than cardiologists, including those using AI assistance, according to the company. Studies representing more than 20 hospitals and 500,000 patients in the US and Canada validated the tool's performance across right and left-sided heart failure, valve disease, severe hypertrophy compatible with infiltrative cardiomyopathy, and pulmonary hypertension.

On June 22, Nature Medicine published what the journal called the first peer-reviewed account of an AI-detected condition leading to a heart transplant — a case in which EchoNext identified undiagnosed heart failure that clinicians had missed. The FDA clearance covers all six indications simultaneously, a regulatory milestone that Pathway Labs said is a first for multi-condition AI in cardiology.

Competitive implications for the AI diagnostics market

The OpenEvidence partnership gives EchoNext immediate distribution to a physician base that covers more than half of US clinicians, bypassing the slow hospital-by-hospital sales cycle that typically plagues new medical device adoption. Travis Zack, chief medical officer of OpenEvidence, said the integration means "a breakthrough in heart disease detection is available everywhere care happens, from major hospitals to community practices."

The clearance positions Pathway Labs against a growing field of AI diagnostic tools in cardiology, though most competitors focus on single-condition detection. Eko Health, HeartFlow, and Viz.ai have each secured FDA clearances for specific cardiac applications, but none cover six indications from a single ECG input. The breadth of EchoNext's clearance could accelerate adoption among health systems seeking to consolidate AI screening tools onto fewer platforms.

Pathway Labs did not disclose pricing or revenue projections. The company's valuation trajectory will depend on how quickly hospitals integrate EchoNext into routine ECG workflows — a process that typically takes 12 to 18 months even after FDA clearance, according to industry estimates. For investors tracking the AI diagnostics theme, the key metric will be procedure volume growth: each of the roughly 100 million ECGs performed annually in the US represents a potential screening event.

This article is for informational purposes only and does not constitute investment advice.