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

HeartBeam Inc. 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 determination. The clearance represents a significant regulatory milestone for the medical technology company, which focuses on transforming cardiac care through personalized insights. The company's patented cable-free 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 capability enables patients to capture meaningful ECG data wherever symptoms occur, potentially improving access to cardiac monitoring outside traditional medical facilities.

With clearance secured, HeartBeam plans a limited U.S. launch in early 2026 with select cardiology groups. The company is simultaneously advancing several related programs, including development in heart attack detection, creation of an on-demand 12-lead extended wear patch, and the development of 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 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. Importantly, the synthesized 12-lead ECG 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. The software does not conduct cardiac analysis and is not intended to replace a standard 12-lead ECG. For full safety information, users should consult the complete Instructions for Use or Clinician Portal Manual available at https://www.heartbeam.com.

HeartBeam's 3D ECG technology previously received FDA clearance for arrhythmia assessment in December 2024, with the 12-lead ECG synthesis software clearance following in December 2025. The company holds over 20 issued patents related to technology enablement and describes its platform technology as designed for portable devices that can be used wherever the patient is to deliver actionable heart intelligence. Additional information about the company is available at https://www.heartbeam.com. This regulatory clearance comes at a time when remote patient monitoring technologies are gaining increased attention in healthcare. The ability to capture meaningful cardiac data outside medical facilities could potentially improve early detection of cardiac issues and enable more timely interventions.

The technology's focus on non-life-threatening arrhythmias positions it as a tool for ongoing monitoring rather than emergency response, with physicians able to identify cardiac health trends and acute conditions while directing patients to appropriate care outside traditional medical settings. The successful appeal and subsequent clearance demonstrate the regulatory pathway for innovative cardiac monitoring technologies that bridge clinical and home environments. As healthcare continues to shift toward more distributed models of care, technologies like HeartBeam's 12-lead ECG synthesis software could play an increasingly important role in managing cardiac health across diverse patient populations and care settings.