HeartBeam (NASDAQ: BEAT) announced study results showing no significant differences in detecting atrial fibrillation, atrial flutter, and sinus rhythm when its deep learning algorithms were applied to the HeartBeam System versus standard 12-lead ECGs. Data from 201 patients, presented at HRX Live 2025 in Atlanta by Dr. Joshua Lampert of Mount Sinai Heart, demonstrated high accuracy rates in both groups (94.5% HeartBeam vs. 95.5% standard 12-lead).
CEO Rob Eno stated that these findings highlight the potential of HeartBeam's compact, 3D device to expand advanced cardiac monitoring to settings where full 12-lead ECGs may be impractical. The company plans to use these results to support future FDA submissions. HeartBeam's 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024, while the 12-Lead ECG synthesis software remains under FDA review.
The implications of this technological advancement are significant for cardiac care accessibility. Traditional 12-lead ECGs require specialized equipment and clinical settings, limiting their availability in remote or home environments. HeartBeam's cable-free device, capable of collecting ECG signals in 3D from three non-coplanar directions and synthesizing them into a 12-lead ECG, could revolutionize how cardiac conditions are monitored outside medical facilities.
This development matters because it addresses critical gaps in cardiac healthcare delivery. Approximately 6 million Americans live with atrial fibrillation, and many remain undiagnosed due to limited access to traditional monitoring equipment. The ability to perform accurate ECG monitoring in non-clinical settings could lead to earlier detection of arrhythmias, potentially preventing strokes and other serious complications. The company holds over 20 issued patents related to this technology enablement, positioning it at the forefront of portable cardiac monitoring innovation.
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