EchoNext AI Gets FDA Clearance to Detect Heart Disease

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- EchoNext is an AI model that lets clinicians upload an EKG image and receive an algorithmic prediction of whether a patient has structural heart disease.
- The model was developed by researchers at New York-Presbyterian Hospital and Columbia University and is being commercialized by a spinout called Pathway Labs.
- Pathway Labs received FDA clearance this month covering seven forms of structural heart disease, including conditions involving blocked or leaky valves and heart chambers that don't pump blood effectively.
- Pathway Labs will license the technology to OpenEvidence, a medical evidence search engine used by hundreds of thousands of clinicians.
- Doctors using OpenEvidence will soon be able to run the EKG-based screening directly within the platform, extending it beyond its current evidence-search function.
- In addition to the OpenEvidence deal, Pathway Labs plans to market the tool to hospitals.
Why it matters: By embedding a diagnostic AI inside a search engine already used by hundreds of thousands of clinicians, Pathway Labs is testing a distribution route that bypasses traditional hospital procurement, potentially making structural heart disease screening available at the point of care far faster than selling to health systems one by one.
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