HeartBeam Inc. (NASDAQ: BEAT) has received FDA 510(k) clearance for its 12-lead ECG synthesis software for arrhythmia assessment following a successful appeal of a prior Not Substantially Equivalent (NSE) determination. This regulatory milestone allows the medical technology company to proceed with its plans to transform cardiac care through portable, cable-free monitoring solutions.
The patented technology captures cardiac electrical signals in three non-coplanar dimensions to generate a synthesized 12-lead electrocardiogram that can be reviewed remotely by board-certified cardiologists. This enables patients to capture meaningful ECG data wherever symptoms occur, potentially revolutionizing how cardiac conditions are monitored outside traditional medical facilities. The clearance represents a significant advancement in making sophisticated cardiac assessment tools more accessible to patients in non-clinical settings.
With FDA clearance secured, HeartBeam plans a limited U.S. launch in early 2026 with select cardiology groups. The company is simultaneously advancing other programs including heart attack detection technology, 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. These developments could significantly expand the capabilities of remote cardiac monitoring and early intervention strategies.
The HeartBeam System is a portable non-invasive recorder intended to record, store, and transfer a patient's 3-lead ECG acquired from five electrodes. The device can be used by adult patients in either clinical settings or at home. The 12-Lead ECG Synthesis Software synthesizes a 12-lead ECG from the HeartBeam System's 3-lead recording device, producing a visual representation similar to standard diagnostic 12-lead ECGs. According to the cleared indications, the synthesized 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.
It is important to note that the software does not conduct cardiac analysis and is not intended to replace a standard 12-lead ECG. The synthesized 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, or any other disorders. For full safety information, healthcare professionals should consult the complete Instructions for Use available at https://ibn.fm/lNbF2 or the Clinician Portal Manual.
HeartBeam's technology platform represents what the company describes as the first-ever cable-free device capable of collecting ECG signals in 3D from three non-coplanar directions and synthesizing them into a 12-lead ECG. The company holds over 20 issued patents related to this technology enablement. This clearance follows the FDA clearance the company received for arrhythmia assessment in December 2024, with the 12-Lead ECG synthesis software clearance coming in December 2025.
The potential impact of this technology extends beyond immediate clinical applications. By enabling remote monitoring and data collection, HeartBeam's platform could facilitate the development of more sophisticated AI algorithms for cardiac health prediction and screening. The ability to collect longitudinal data from patients in their natural environments could provide insights previously unavailable through periodic clinical visits alone. This advancement comes at a time when remote patient monitoring and telehealth solutions are becoming increasingly important components of healthcare delivery systems worldwide.
