Clearance covers the cable-free 12-lead ECG in the assessment of arrhythmias. The system, unlike any single-lead or six-lead consumer device, captures the heart’s electrical signals in three non-coplanar dimensions and synthesizes them into 12-lead ECG representation. It enables the patient to obtain an ECG reading from the comfort of their own home or wherever they happen to be.

Following the ECG capture, an on-demand, board-certified cardiologist promptly reviews the reading.

Data from the VALID-ECG study formed the basis of HeartBeam’s FDA application for the 12-lead ECG synthesis software. The company submitted for approval in January 2025, reporting findings that met endpoints in April.