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FAQ: HeartBeam's FDA-Cleared 12-Lead ECG Synthesis Software and Cardiac Care Technology
TL;DR
HeartBeam's FDA-cleared 12-lead ECG software offers a competitive edge by enabling remote cardiac monitoring, potentially capturing market share in telemedicine and personalized healthcare.
HeartBeam's technology uses cable-free 3D signal capture from five electrodes to synthesize a 12-lead ECG for physician review, with FDA clearance for arrhythmia assessment.
This technology improves cardiac care accessibility by allowing patients to capture ECG data anywhere, facilitating early detection and better management of heart conditions.
HeartBeam's portable 3D ECG device can record heart signals from three directions, creating a synthesized 12-lead readout without traditional cables or clinical visits.
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HeartBeam Inc. has secured 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 management outside medical facilities.
HeartBeam plans a limited U.S. launch in early 2026 with select cardiology groups.
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.
The synthesized 12-lead ECG output 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 device does not conduct cardiac analysis itself and requires manual interpretation by a physician, and the synthesized output is not intended for assessment of other arrhythmias or conditions like ventricular arrhythmias, hypertrophy, conduction disorders, myocardial infarction, ischemia, or pacemaker functions.
HeartBeam's 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024, and the 12-Lead ECG synthesis software received clearance in December 2025.
For additional information, visit HeartBeam.com or view the full press release at https://ibn.fm/lNbF2.
Curated from InvestorBrandNetwork (IBN)
