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HeartBeam Advances Cardiac Care with FDA-Cleared Cable-Free ECG Technology, Prepares for Commercial Launch

By Burstable Health Team

TL;DR

HeartBeam's FDA-cleared portable ECG technology offers investors early access to a disruptive cardiac care platform ahead of its 2026 commercial launch.

HeartBeam's cable-free system uses 3D ECG signals from five electrodes to synthesize 12-lead ECGs for arrhythmia assessment, with FDA clearance and over 20 patents.

This portable ECG technology enables cardiac monitoring outside medical facilities, improving early detection and access to care for patients with heart conditions.

HeartBeam's innovative cable-free device creates 12-lead ECGs from 3D signals, transforming how cardiac health is monitored beyond traditional clinical settings.

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HeartBeam Advances Cardiac Care with FDA-Cleared Cable-Free ECG Technology, Prepares for Commercial Launch

HeartBeam Inc. will attend the JP Morgan 2026 Annual Healthcare Conference in San Francisco from January 12 to 15, 2026, where company executives will meet with investors and potential partners. This appearance coincides with the company's transition from development to commercialization phase following recent regulatory milestones. The medical technology company recently received 510(k) clearance from the U.S. Food and Drug Administration for its patented cable-free 12-lead electrocardiogram synthesis software for arrhythmia assessment, positioning it for a limited U.S. commercial launch in the first quarter of 2026.

The company's platform represents a significant advancement in cardiac care technology. HeartBeam is creating the first cable-free device capable of collecting ECG signals in three dimensions from three non-coplanar directions and synthesizing these signals into a 12-lead ECG. This technology enables portable devices to deliver actionable heart intelligence wherever patients are located, potentially allowing physicians to identify cardiac health trends and acute conditions outside traditional medical facilities. The company holds over 20 issued patents related to this technology enablement.

The FDA clearance specifically covers the HeartBeam System as a portable non-invasive recorder intended to record, store, and transfer a patient's 3-lead ECG acquired from five electrodes. The device is designed for adult patients in either clinical or home settings and does not conduct cardiac analysis itself. When used with the companion ECG Viewer software system, it enables manual interpretation of non-life-threatening arrhythmias by healthcare professionals.

The HeartBeam 12-Lead ECG Synthesis Software synthesizes a 12-lead ECG from the system's 3-lead recordings, producing a visual representation similar to standard diagnostic 12-lead ECGs. The software is cleared 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. According to the cleared indications, the synthesized output is not intended for assessment of other arrhythmias or conditions including other atrial arrhythmias, ventricular arrhythmias, hypertrophy, conduction disorders, myocardial infarction or ischemia, pacemaker functions, localization of arrhythmia foci, or ECG wave abnormalities.

The technology's development timeline shows progressive regulatory approvals, with the 3D ECG technology receiving FDA clearance for arrhythmia assessment in December 2024 and the 12-Lead ECG synthesis software following in December 2025. For additional information about the company's technology and developments, visit https://HeartBeam.com. The company's presence at the JP Morgan conference signals its readiness to engage with the investment community as it prepares to bring this innovative cardiac monitoring solution to market.

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Burstable Health Team

Burstable Health Team

@burstable

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