FDA Clears EchoNext AI Tool to Detect Hidden Heart Disease from Routine ECGs

The FDA has cleared EchoNext, an artificial intelligence tool that can detect structural heart disease from a routine electrocardiogram before a patient shows any symptoms.

Pathway Labs, the company behind EchoNext, raised $8.5 million to develop and commercialize the tool. The AI analyzes ECG data and flags patients who may have undiagnosed heart conditions, giving doctors a chance to intervene earlier.

Structural heart disease, which includes conditions like aortic stenosis and hypertrophic cardiomyopathy, often goes undetected until it causes a serious event. Standard ECGs are widely available and inexpensive, making them a practical screening tool if AI can reliably extract more information from the data.

Pathway Labs says EchoNext performs with high accuracy in clinical testing. The FDA clearance allows the company to market the tool to hospitals and cardiology practices across the United States.

Cardiologists not involved in the development called the clearance a meaningful step. They noted that earlier detection of structural disease can significantly improve outcomes, particularly for patients who would otherwise not receive an echocardiogram until symptoms appear.

The tool is expected to be available to health systems later this year.