HeartBeam, a medical technology company, has received FDA 510(k) clearance for its 12-lead ECG synthesis software for arrhythmia assessment after successfully appealing a prior not substantially equivalent (NSE) determination. The patented cable-free technology captures cardiac electrical signals in three non-coplanar dimensions to generate a synthesized 12-lead ECG that can be reviewed remotely by a board-certified cardiologist. This enables patients to capture meaningful ECG data wherever symptoms occur, potentially transforming how cardiac conditions are monitored outside traditional medical facilities.
With clearance secured, HeartBeam plans a limited U.S. launch in early 2026 with select cardiology groups. The company is also advancing programs in heart attack detection, developing an on-demand 12-lead extended wear patch, and creating AI-powered screening and prediction algorithms driven by longitudinal data from its 3D ECG platform. The technology represents what the company describes as the first-ever cable-free device capable of collecting ECG signals in 3D and synthesizing them into a 12-lead ECG, designed for portable use wherever the patient is located.
The cleared software synthesizes a 12-lead ECG from the HeartBeam System's 3-lead recording device, producing a visual representation similar to a standard diagnostic 12-lead ECG. According to the cleared indications, the output is intended for manual assessment of normal sinus rhythm and specific non-life-threatening arrhythmias including sinus arrhythmia, sinus tachycardia, sinus bradycardia, atrial premature complexes, atrial fibrillation, and ventricular premature complex. The software is not intended for assessment of other conditions such as myocardial infarction, ischemia, or life-threatening arrhythmias, and does not conduct cardiac analysis itself.
For full safety information, refer to the complete Instructions for Use or Clinician Portal Manual. The company holds over 20 issued patents related to this technology enablement. This development follows the FDA clearance of HeartBeam's 3D ECG technology for arrhythmia assessment in December 2024, with the 12-Lead ECG synthesis software receiving clearance in December 2025. The platform is designed to help physicians identify cardiac health trends and acute conditions while directing patients to appropriate care outside medical facilities, potentially redefining cardiac health management approaches.
