AI company founded by cardiologist gains FDA clearance, raises $8.5M
Pathway Labs, a New York-based artificial intelligence (AI) company founded by a cardiologist, has received U.S. Food and Drug Administration (FDA) clearance for its EchoNext screening tool that detects signs of structural heart disease in electrocardiograms (ECGs).
“We have colonoscopies, we have mammograms, but we have not had equivalents for most forms of heart disease,” Pierre Elias, MD, Pathway Labs founder and CEO, 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, said in a statement. “Through EchoNext, we are able to diagnose critical, high-risk conditions that the human eye can’t, and potentially deliver lifesaving treatment earlier.”
EchoNext was cleared to identify a total of six different types of heart disease, flagging ECG results when a follow-up echocardiogram is recommended. The advanced algorithm was trained on more than 700,000 ECG-echo pairs. Recent studies have found that it can identify structural heart disease with a greater accuracy than trained cardiologists.
Pathway Labs celebrated these clearances by officially launching EchoNext. The company has also partnered OpenEvidence to help expand access to the algorithm throughout the United States.
Pathway Labs secures new investments
Pathway Labs has also raised $8.5 million to help expand its reach and support ongoing R&D efforts. AlleyCorp and Breyer Capital led the funding round.
“Pathway Labs is going to save and improve so many lives by diagnosing heart disease sooner and enabling more effective therapeutic intervention,” Alexi Nazem, MD, general partner at AlleyCorp and hospitalist at NewYork Presbyterian Hospital, said in the same statement. “This remarkable technology is pioneering a new type of medicine where AI enables unprecedented capabilities, detecting latent signals in standard diagnostic tests.”
“One of the most compelling opportunities in medical AI is uncovering clinically meaningful signals from data we already collect,” added Morgan Cheatham, MD, partner and head of healthcare and life sciences at Breyer Capital. “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.”
