Austin, Texas, United States, December 10th, 2025, FinanceWire
HeartBeam (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through personalized insights, has received FDA 510(k) clearance for its 12-lead ECG synthesis software for arrhythmia assessment, after successfully appealing an earlier NSE determination. The patented cable-free technology captures cardiac electrical signals in three non-coplanar dimensions to generate a synthesized 12-lead ECG that a board-certified cardiologist can review remotely, so that patients can capture meaningful ECG data wherever symptoms occur. With clearance secured, HeartBeam plans a limited U.S. launch in early 2026 with select cardiology groups. It will also advance programs in heart attack detection, develop an on-demand 12-lead extended wear patch and create AI-powered screening and prediction algorithms driven by longitudinal data from its 3D ECG platform.
The full press release can be viewed at https://ibn.fm/36RSg
About HeartBeam Inc.
HeartBeam Inc. is a medical technology company set on transforming the detection and monitoring of critical cardiac conditions. The Company is creating the first-ever cable-free device able to collect ECG signals in 3D, from three non-coplanar directions, and to synthesize the signals into a 12-lead ECG. This platform technology is designed for portable devices that can be used wherever the patient is, to deliver actionable heart intelligence. Physicians will be able to identify cardiac health trends and acute conditions and direct patients to the appropriate care, all outside a medical facility, thus redefining the future of cardiac health management. HeartBeam’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024, and the 12-Lead ECG synthesis software in December 2025(1). The Company holds over 20 issued patents related to technology enablement. Further information is available at HeartBeam.com.
(1)Cleared Indications for Use 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 use by adult patients in either a clinical setting or at home. 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 HeartBeam 12-Lead ECG Synthesis Software synthesizes a 12-Lead ECG from the HeartBeam System 3-Leads (in three-directions) recording device, and produces a visual 12-Lead ECG representation that is similar, but not identical, to the same leads of a standard diagnostic 12-Lead ECG. The synthesized 12-Lead ECG output is intended solely for manual assessment of normal sinus rhythm and the following non-life-threatening arrhythmias: sinus arrhythmia, sinus tachycardia, sinus bradycardia, atrial premature complexes, atrial fibrillation, and ventricular premature complex. It is not intended for the assessment of any other arrhythmia or conditions (including but not limited to: other atrial arrhythmias, ventricular arrhythmias, hypertrophy, conduction disorders, myocardial infarction or ischemia, pacemaker functions, localization of arrhythmia foci, ECG wave abnormalities, and/or any other disorder). The software does not conduct cardiac analysis and is not intended to replace a standard 12-Lead ECG. The 12-Lead ECG Synthesis Software is intended for adult use only.
Full safety information is available in the Instructions for Use or the Clinician Portal Manual.
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