FDA-cleared AI tool EchoNext screens for structural heart disease from EKGs
Tags AI · Enterprise
Pathway Labs received FDA clearance for EchoNext, an AI model developed at NY-Presbyterian/Columbia that detects seven forms of structural heart disease from a standard EKG. The tool will be distributed via OpenEvidence, a medical evidence search engine used by hundreds of thousands of clinicians. Doctors can upload an EKG image and receive an algorithmic prediction of structural heart disease including valve disorders and chamber pumping defects.
Technical significance
EchoNext's FDA clearance demonstrates that AI models trained on specialized clinical data can achieve regulatory approval for diagnostic use. The distribution via OpenEvidence suggests a new model where AI diagnostic tools reach clinicians through evidence-based medicine platforms rather than traditional EHR integrations.