FDA Clears AI Tool That Detects Hidden Heart Disease from Routine ECG

The FDA cleared an artificial intelligence tool called EchoNext in June 2026 to detect structural heart disease from a standard 12-lead electrocardiogram. The tool, developed by Pathway Labs, is the first FDA-cleared AI capable of flagging multiple forms of structural heart disease from a routine ECG.

Structural heart disease involves mechanical problems with the heart's walls, chambers, or valves. These conditions often produce no symptoms until they become severe, and they are typically confirmed only through echocardiography, a more expensive and less widely available test. EchoNext analyzes ECG waveforms to identify patients who need further evaluation.

The tool is cleared to detect six conditions: left-sided heart failure, right-sided heart failure, valve disease, pulmonary hypertension, severe thickening of the heart muscle, and one additional structural abnormality. Pathway Labs trained the model on more than 700,000 paired ECG and echocardiogram records.

In a 2025 validation study, EchoNext correctly identified 77% of structural heart problems. Cardiologists interpreting the same ECG data achieved 64% accuracy. Researchers found no clinically significant differences in performance across racial, ethnic, or sex-based groups.

A case published in Nature Medicine in June 2026 documented the first patient to receive a heart transplant following an AI-driven EchoNext diagnosis of previously undetected heart failure.

Pathway Labs has partnered with OpenEvidence, a clinical decision support platform used by more than 500,000 physicians, to integrate EchoNext into everyday clinical workflows. The company recently raised $8.5 million in seed funding to support broader deployment.

Medical experts say the tool should serve as a supplement to clinical judgment, not a replacement for it.