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 Non-Substantial Equivalence (NSE) determination. The clearance marks a significant milestone for the medical technology company, which is developing a cable-free device that captures cardiac electrical signals in three non-coplanar dimensions to generate a synthesized 12-lead ECG. This technology allows patients to record ECG data wherever symptoms occur and have it reviewed remotely by a board-certified cardiologist.
The FDA clearance covers the HeartBeam 12-Lead ECG Synthesis Software, which synthesizes a 12-lead ECG from the HeartBeam System's 3-lead recordings. The synthesized output 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 does not conduct cardiac analysis and is not intended to replace a standard 12-lead ECG.
With this clearance, HeartBeam plans a limited U.S. launch in early 2026 with select cardiology groups. The company is also 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. The company holds over 20 issued patents related to its technology.
“This clearance represents a significant step forward in our mission to transform cardiac care,” said a company spokesperson. “Patients will now have access to a portable, cable-free device that provides meaningful ECG data for arrhythmia assessment, enabling timely intervention and potentially improving outcomes.”
The HeartBeam System is a portable non-invasive recorder that records, stores, and transfers a patient’s 3-lead ECG acquired from five electrodes. It is intended for adult use in clinical or home settings and does not conduct cardiac analysis. The system is used with an ECG Viewer software for manual interpretation of non-life-threatening arrhythmias by a healthcare professional.
For full safety information, refer to the Instructions for Use or Clinician Portal Manual available on the company’s website. More details about the clearance can be found in the full press release at https://ibn.fm/lNbF2. For the latest news and updates on HeartBeam, visit the company’s newsroom at https://ibn.fm/BEAT.
