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FAQ: HeartBeam's FDA-Cleared 12-Lead ECG Synthesis Software
TL;DR
HeartBeam's FDA-cleared 12-lead ECG synthesis software gives patients and cardiologists a competitive edge by enabling remote cardiac monitoring anywhere symptoms occur.
HeartBeam's patented technology captures 3D cardiac signals using cable-free electrodes and synthesizes them into a 12-lead ECG for remote cardiologist review.
This technology makes cardiac care more accessible by allowing patients to capture meaningful ECG data wherever they are, potentially saving lives through early detection.
HeartBeam transforms cardiac monitoring with cable-free 3D ECG technology that synthesizes 12-lead readings for remote review, launching in early 2026.
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HeartBeam (NASDAQ: BEAT) has received FDA 510(k) clearance for its 12-lead ECG synthesis software for arrhythmia assessment after successfully appealing a prior NSE determination.
HeartBeam uses patented cable-free technology that captures cardiac electrical signals in three non-coplanar dimensions to generate a synthesized 12-lead ECG, creating the first-ever cable-free device capable of collecting ECG signals in 3D.
Patients can capture meaningful ECG data wherever symptoms occur, and board-certified cardiologists can review the synthesized 12-lead ECG remotely, enabling cardiac health monitoring outside of medical facilities.
HeartBeam plans a limited U.S. launch in early 2026 with select cardiology groups.
The software is intended for manual assessment of normal sinus rhythm and 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 atrial arrhythmias, ventricular arrhythmias, hypertrophy, conduction disorders, myocardial infarction or ischemia, pacemaker functions, localization of arrhythmia foci, ECG wave abnormalities, or any other disorders.
HeartBeam is 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.
HeartBeam Inc. is a medical technology company focused on transforming cardiac care detection and monitoring, and holds over 20 issued patents related to technology enablement.
For additional information, visit HeartBeam.com or view the full press release at https://ibn.fm/36RSg.
Curated from NewMediaWire
