HeartBeam’s VALID-ECG Study of 12-Lead ECG Synthesis Tech Meets Endpoints

HeartBeam revealed that its synthesized 12-lead electrocardiogram (ECG) met the clinical endpoints in its VALID-ECG study. The data was presented at this year’s Heart Rhythm Society annual meeting.

The VALID-ECG study was a multicenter trial enrolling 198 patients in five U.S. clinical sites.

The study assessed the average difference in ECG intervals and amplitudes between HeartBeam’s synthesized 12-lead ECG and simultaneously collected standard 12-lead ECG important to evaluate non-life-threatening arrhythmias. Data demonstrated 93.4% overall diagnostic agreement.

This shows HeartBeam’s 12-lead synthesized ECG can support arrythmia diagnosis in a manner consistent with standard 12-lead ECGs.

The company’s 3D ECG tech captures the heart’s electrical signals in three non-coplanar directions, then synthesizes the signals into a 12-lead ECG with a personalized transformation matrix. VALID-ECG study data was the basis of the U.S. Food and Drug Administration (FDA) application for the 12-lead synthesis software that HeartBeam submitted in January 2025.

Once FDA clearance is obtained, the company plans to begin commercialization. HeartBeam also recently began an Early Access Program to gather feedback on the end-to-end clinical workflow, ensure operational readiness, and establish an early adopter funnel in anticipation of U.S. commercialization.

“This important milestone successfully confirms that our novel technology can deliver diagnostic insights similar to a standard 12-lead ECGs for arrhythmia assessment,” said HeartBeam CEO Robert Eno. “The ability to deliver 12-lead ECG-like data through a credit card-sized device that patients can use whenever and wherever arrhythmia symptoms occur underscores our long-term vision of bringing advanced cardiac health insights beyond medical facilities to improve patient outcomes.”

Last week, the company begun a strategic collaboration that aims to enhance accessibility of cardiac monitoring solutions by making AccurKardia’s FDA-cleared AccurECG ECG analysis software available on HeartBeam’s devices.