HeartBeam (Nasdaq:BEAT) announced today that it received FDA 510(k) clearance for its 12-lead electrocardiogram (ECG) synthesis software.
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.
With FDA clearance, the company plans to initiate a limited U.S. launch in the first quarter of 2026. Early adopters include select concierge and preventive cardiology practices already signaling strong interest.
HeartBeam hopes to bring its ECG technology to patients with an extended-wear 12-lead patch. It has a working prototype under development, it said. Additionally, the company plans to pursue a heart attack detection indication.
The company expects to share further details on a broader rollout, wearable integration, AI-enabled automated insights and its heart attack detection program in the near future.
“The Company wishes to thank the FDA for its expeditious and constructive engagement throughout the review and appeal process, as well as its thorough evaluation of HeartBeam’s clinical data,” said HeartBeam CEO Robert Eno. “This FDA clearance is a defining moment for HeartBeam, and the true beginning of our mission to revolutionize cardiac care. We look forward to initiating our U.S. market introduction while advancing our efforts on heart attack detection, an on-demand 12-lead extended wear patch, and AI-based screening and prediction algorithms trained on our unique longitudinal data.”
