HeartBeam has received FDA 510(k) clearance for its 12-lead ECG synthesis software for arrhythmia assessment after successfully appealing a prior NSE determination. This clearance represents a significant milestone for the medical technology company and has important implications for cardiac care delivery.
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 addressing a critical gap in cardiac monitoring. The software synthesizes a 12-lead ECG from the HeartBeam System's 3-lead recording device, producing a visual representation that is similar, but not identical, to the same leads of a standard diagnostic 12-lead ECG.
The clearance is specifically for manual assessment of normal sinus rhythm and several non-life-threatening arrhythmias including sinus arrhythmia, sinus tachycardia, sinus bradycardia, atrial premature complexes, atrial fibrillation, and ventricular premature complex. According to the cleared indications for use, the synthesized 12-lead ECG output is not intended for assessment of other arrhythmias or conditions including other atrial arrhythmias, ventricular arrhythmias, hypertrophy, conduction disorders, myocardial infarction or ischemia, pacemaker functions, localization of arrhythmia foci, ECG wave abnormalities, and other disorders. The software does not conduct cardiac analysis and is not intended to replace a standard 12-lead ECG.
With clearance in hand, HeartBeam plans a limited U.S. launch in early 2026 with select cardiology groups. The company is also advancing programs in heart attack detection, development of an on-demand 12-lead extended wear patch, and the creation of AI-powered screening and prediction algorithms driven by longitudinal data from its 3D ECG platform. The company's 3D ECG technology previously received FDA clearance for arrhythmia assessment in December 2024, and the company holds over 20 issued patents related to technology enablement.
The importance of this development lies in its potential to transform cardiac monitoring by enabling remote assessment of cardiac conditions. This technology could allow physicians to identify cardiac health trends and acute conditions and direct patients to appropriate care outside of medical facilities. For patients experiencing symptoms, this means potentially faster assessment without requiring immediate travel to a healthcare facility. For the healthcare system, this represents a step toward more distributed cardiac care that could reduce unnecessary emergency room visits while improving monitoring of chronic conditions.
The HeartBeam System is a portable non-invasive recorder intended to record, store, and transfer a patient's 3-lead electrocardiogram acquired from 5 electrodes. The device is intended for use by adult patients in either a clinical setting or at home. For full safety information, see the full Instructions for Use or Clinician Portal Manual. The latest news and updates relating to BEAT are available in the company's newsroom at https://ibn.fm/BEAT.
