Articles from Pathway Labs

Pathway Labs Announces World's First FDA Clearance for Multicondition AI in Cardiology and Partnership with OpenEvidence
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.
By Pathway Labs · Via Business Wire · June 23, 2026
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