HeartBeam (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through personalized insights, announced today that it 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, marking a significant milestone for the company.
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. This enables patients to capture meaningful ECG data wherever symptoms occur, potentially improving detection and monitoring of arrhythmias outside clinical settings.
With clearance in hand, HeartBeam plans a limited U.S. launch in early 2026 with select cardiology groups. The company is also 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 HeartBeam System is a portable non-invasive recorder intended to record, store, and transfer a patient’s 3-Lead (in three-directions) electrocardiogram (ECG) acquired from 5 electrodes. The device is intended for adult patients in either a clinical setting or at home. The 12-Lead ECG Synthesis Software synthesizes a 12-Lead ECG from the HeartBeam System’s 3-Lead recording, producing a visual representation that is similar, but not identical, to a standard diagnostic 12-Lead ECG.
The synthesized output is cleared for manual assessment of normal sinus rhythm and specific non-life-threatening arrhythmias: sinus arrhythmia, sinus tachycardia, sinus bradycardia, atrial premature complexes, atrial fibrillation, and ventricular premature complex. It is not intended for assessment of other conditions, including myocardial infarction or ischemia, and does not replace a standard 12-Lead ECG.
HeartBeam holds over 20 issued patents related to technology enablement. The company’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024. For full safety information, see the full Instructions for Use or Clinician Portal Manual available at HeartBeam.com.
Forward-looking statements in this release involve risks and uncertainties, including those set forth under "Risk Factors" in the company's SEC filings. For more details, visit the company’s newsroom at https://ibn.fm/BEAT.
