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

HeartBeam Inc. (NASDAQ: BEAT) has received FDA 510(k) clearance for its 12-lead ECG synthesis software for arrhythmia assessment after successfully appealing a prior NSE determination. The company's 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 board-certified cardiologists, allowing patients to capture meaningful ECG data wherever symptoms occur. This development represents a significant advancement in remote cardiac monitoring technology that could transform how arrhythmias are detected and managed outside traditional clinical settings.

With clearance secured, 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. These initiatives build upon the company's broader vision of transforming cardiac care through personalized insights and portable technology. 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, designed for use 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 12-lead ECG representation that is similar, but not identical, to the same leads of a standard diagnostic 12-lead ECG. According to the cleared indications for use, 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. The software does not conduct cardiac analysis and is not intended to replace a standard 12-lead ECG, with full safety information available in the Instructions for Use or Clinician Portal Manual.

This FDA clearance follows the company's earlier achievement of receiving FDA clearance for arrhythmia assessment in December 2024. HeartBeam holds over 20 issued patents related to technology enablement, underscoring the proprietary nature of its innovations. The company's platform technology is designed for portable devices that can be used wherever the patient is to deliver actionable heart intelligence, potentially enabling physicians to identify cardiac health trends and acute conditions and direct patients to appropriate care outside medical facilities. For additional information about the company's technology and developments, visit HeartBeam.com.

The implications of this FDA clearance extend beyond immediate commercial opportunities. By enabling remote capture and synthesis of 12-lead ECG data, the technology addresses critical gaps in cardiac care accessibility and continuity. Patients experiencing intermittent symptoms can now capture clinically relevant data during episodes, potentially leading to more accurate diagnoses and timely interventions. The planned integration of AI-powered algorithms with longitudinal data collection could further enhance predictive capabilities, moving cardiac care from reactive treatment toward proactive management. This development occurs within a broader trend toward decentralized healthcare delivery and remote patient monitoring, positioning HeartBeam's technology at the intersection of medical innovation and evolving care models.