HeartBeam Secures FDA Clearance for 12-Lead ECG Synthesis Software Following Successful Appeal

HeartBeam Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through personalized insights, has received FDA 510(k) clearance for its 12-lead ECG synthesis software for arrhythmia assessment. The clearance follows a successful appeal of a prior Not Substantially Equivalent (NSE) determination by the regulatory agency. This development marks a significant regulatory milestone for the company's innovative cardiac monitoring platform.

The company's patented cable-free technology captures cardiac electrical signals in three non-coplanar dimensions to generate a synthesized 12-lead electrocardiogram (ECG) that can be reviewed remotely by board-certified cardiologists. This capability enables patients to capture meaningful ECG data wherever symptoms occur, potentially transforming how cardiac conditions are monitored outside traditional medical facilities. The technology represents what HeartBeam describes as the first-ever cable-free device capable of collecting ECG signals in 3D from three non-coplanar directions and synthesizing these signals into a 12-lead ECG.

According to the cleared indications for use, 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 is designed 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 12-lead ECG representation that is similar, but not identical, to the same leads of a standard diagnostic 12-lead ECG.

The synthesized 12-lead ECG 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 explicitly excludes assessment of other 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 company emphasizes that the software does not conduct cardiac analysis and is not intended to replace a standard 12-lead ECG.

With regulatory clearance secured, HeartBeam plans a limited U.S. launch in early 2026 with select cardiology groups. The company is simultaneously advancing additional 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. These developments build upon the company's existing intellectual property portfolio, which includes over 20 issued patents related to technology enablement.

The implications of this FDA clearance extend beyond HeartBeam's immediate business plans. The technology addresses growing needs in remote patient monitoring and telemedicine, particularly relevant in a healthcare landscape increasingly focused on decentralized care. By enabling patients to capture cardiac data during symptomatic episodes wherever they occur, the platform could potentially reduce delays in diagnosis and treatment for cardiac conditions. The ability to generate synthesized 12-lead ECGs from portable 3D recordings represents an advancement in making comprehensive cardiac assessment more accessible outside traditional clinical settings.

For full safety information, healthcare professionals and patients can refer to the complete Instructions for Use or Clinician Portal Manual available through the company's official channels. Additional information about HeartBeam's technology and corporate developments is available through the company's investor relations resources at https://ibn.fm/BEAT. The broader context of medical technology innovation and regulatory pathways can be explored through industry resources such as https://www.InvestorWire.com, which provides specialized communications services for the investment community.