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

HeartBeam, a medical technology company focused on transforming cardiac care through personalized insights, received FDA 510(k) clearance for its 12-lead ECG synthesis software for arrhythmia assessment after successfully appealing a prior 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, enabling patients to capture meaningful ECG data wherever symptoms occur. This clearance represents a critical regulatory milestone for the company's portable cardiac monitoring platform.

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 to be used by adult patients in either a clinical setting or at home. The HeartBeam 12-Lead ECG Synthesis Software synthesizes a 12-Lead ECG from the HeartBeam System 3-Leads 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 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.

With clearance in hand, HeartBeam plans a limited U.S. launch in early 2026 with select cardiology groups, alongside 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 technology platform is designed for portable devices that can be used wherever the patient is to deliver actionable heart intelligence. Physicians will be able to identify cardiac health trends and acute conditions and direct patients to the appropriate care – all outside of a medical facility, thus redefining the future of cardiac health management.

HeartBeam's 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024 and the 12-Lead ECG synthesis software in December 2025. The Company holds over 20 issued patents related to technology enablement. For additional information, visit HeartBeam.com. The latest news and updates relating to BEAT are available in the company's newsroom at https://ibn.fm/BEAT. For full safety information, see the full Instructions for Use or Clinician Portal Manual. Please see full terms of use and disclaimers on the InvestorBrandNetwork website applicable to all content provided by IBN, wherever published or re-published: http://IBN.fm/Disclaimer.

The clearance matters because it enables remote cardiac monitoring capabilities that could significantly improve patient access to cardiac care and potentially reduce healthcare costs associated with traditional in-clinic ECG monitoring. By allowing patients to capture ECG data wherever symptoms occur and enabling remote review by cardiologists, this technology addresses a critical gap in cardiac care accessibility. The successful appeal of the prior NSE determination demonstrates regulatory validation of the technology's safety and effectiveness for its intended use. This development positions HeartBeam to expand its cardiac monitoring solutions and potentially transform how cardiac conditions are detected and managed outside traditional medical facilities.