HeartBeam wins FDA nod for at-home ECG tech

HeartBeam (Nasdaq:BEAT) announced today that it received FDA 510(k) clearance for its comprehensive arrhythmia assessment system.

Santa Clara, California–based HeartBeam said its device — a high-fidelity electrocardiogram (ECG) system — is the first of its kind to receive FDA clearance. It features a credit card-sized form factor and cable-free design. The device captures heart signals from three distinct directions for actionable heart health information.

When a patient feels symptoms, the app guides them through the process of placing the device on their chest and capturing a 30-second recording. Once taken, the device sends signals to the cloud and processes them before sending them to a physician for review. The physician reviews the ECG recording and follows up with the next steps.

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