HeartBeam (NASDAQ: BEAT) reported financial and operational results for the fourth quarter and full year ended Dec. 31, 2025, emphasizing progress toward commercialization following U.S. Food and Drug Administration 510(k) clearance of its 12-lead electrocardiogram (ECG) synthesis software in December 2025. The company has initiated a limited market launch targeting concierge and preventive cardiology groups, securing its first commercial partnership with ClearCardio. Additionally, HeartBeam has begun enrolling patients in its ALIGN-ACS pilot study evaluating the HeartBeam System for heart attack detection.
The company also completed a prototype extended-wear 12-lead ECG patch and formed a strategic collaboration with the Icahn School of Medicine at Mount Sinai to advance AI-enabled ECG algorithms. A new chief commercial officer has been appointed to support growth initiatives. These developments underscore HeartBeam's commitment to making its 3D ECG technology widely available outside traditional medical facilities.
HeartBeam’s platform technology is designed to collect ECG signals in 3D from three non-coplanar directions, synthesizing them into a 12-lead ECG. The device received FDA clearance for arrhythmia assessment in December 2024 and for the 12-lead ECG synthesis software in December 2025. The company holds over 20 issued patents related to its technology.
The full press release is available at https://ibn.fm/3KQqG. More information about HeartBeam can be found at their newsroom at https://ibn.fm/BEAT.
Forward-looking statements in this article are subject to risks and uncertainties as detailed in the company's SEC filings.
