HeartBeam Receives FDA Clearance for 12-Lead ECG Synthesis Software After Successful Appeal
TL;DR
HeartBeam's FDA-cleared 12-lead ECG synthesis software gives patients and cardiologists a competitive edge by enabling remote cardiac monitoring anywhere symptoms occur.
HeartBeam's patented technology captures 3D cardiac signals using cable-free electrodes and synthesizes them into a 12-lead ECG for remote cardiologist review.
This technology makes cardiac care more accessible by allowing patients to capture meaningful ECG data wherever they are, potentially saving lives through early detection.
HeartBeam transforms cardiac monitoring with cable-free 3D ECG technology that synthesizes 12-lead readings for remote review, launching in early 2026.
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HeartBeam has received FDA 510(k) clearance for its 12-lead ECG synthesis software for arrhythmia assessment after successfully appealing a prior NSE determination. The clearance represents a pivotal regulatory milestone for the company's cable-free cardiac monitoring technology, which captures cardiac electrical signals in three non-coplanar dimensions to generate a synthesized 12-lead ECG that can be reviewed remotely by board-certified cardiologists. The patented technology enables patients to capture meaningful ECG data wherever symptoms occur, potentially transforming how cardiac conditions are monitored outside traditional medical facilities.
With this clearance in hand, HeartBeam plans a limited U.S. launch in early 2026 with select cardiology groups. The company is simultaneously 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 HeartBeam System is a portable non-invasive recorder intended to record, store, and transfer a patient's 3-lead electrocardiogram acquired from five electrodes. According to the cleared indications for use, the device is intended for adult patients in either clinical settings or at home and does not conduct cardiac analysis itself.
The 12-Lead ECG Synthesis 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 synthesized output is solely 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. Importantly, the software 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. The company emphasizes that the software does not conduct cardiac analysis and is not intended to replace a standard 12-lead ECG.
HeartBeam's technology 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 the signals into a 12-lead ECG. This platform technology is designed for portable devices that can be used wherever the patient is located to deliver actionable heart intelligence. Physicians will potentially be able to identify cardiac health trends and acute conditions and direct patients to appropriate care outside of medical facilities. The company holds over 20 issued patents related to technology enablement, with additional information available at https://HeartBeam.com. For full safety information, users should consult the complete Instructions for Use or Clinician Portal Manual.
Curated from NewMediaWire
