HeartBeam Inc. (NASDAQ: BEAT) has received FDA 510(k) clearance for its 12-lead ECG synthesis software for arrhythmia assessment, following a successful appeal of a prior NSE determination. The clearance marks a significant regulatory milestone for the medical technology company, which is focused on transforming cardiac care through personalized insights. 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 early detection and management of arrhythmias.
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. These initiatives underscore HeartBeam's commitment to expanding its technology's applications beyond arrhythmia assessment.
HeartBeam's 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024, and the 12-lead ECG synthesis software followed in December 2025. The HeartBeam System is a portable non-invasive recorder intended to record, store, and transfer a patient's 3-lead ECG acquired from 5 electrodes. The device does not conduct cardiac analysis and can be used with an ECG Viewer software system for manual interpretation of non-life-threatening arrhythmias by a physician or healthcare professional.
The synthesized 12-lead ECG output is similar, but not identical, to a standard diagnostic 12-lead ECG and 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 is not intended for assessment of other arrhythmias or conditions, such as myocardial infarction or ischemia, and does not replace a standard 12-lead ECG. The 12-lead ECG Synthesis Software is intended for adult use only.
HeartBeam holds over 20 issued patents related to technology enablement. The company is dedicated to transforming the detection and monitoring of critical cardiac conditions, creating the first-ever cable-free device capable of collecting ECG signals in 3D and synthesizing them into a 12-lead ECG. This platform technology is designed for portable devices that can be used wherever the patient is, delivering actionable heart intelligence to physicians for identifying cardiac health trends and acute conditions outside of a medical facility.
For full safety information, see the full Instructions for Use or Clinician Portal Manual. The latest news and updates relating to BEAT are available in the company's newsroom at https://ibn.fm/BEAT.
