HeartBeam (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care, reported financial and operational results for the fourth quarter and full year ended December 31, 2025, highlighting significant progress toward commercialization. The company received U.S. Food and Drug Administration 510(k) clearance for its 12-lead electrocardiogram (ECG) synthesis software in December 2025, a milestone that has enabled a limited market launch targeting concierge and preventive cardiology groups.
HeartBeam has secured its first commercial partnership with ClearCardio and has begun enrolling initial patients in its ALIGN-ACS pilot study, which evaluates the HeartBeam System for heart attack detection. Additional developments include the completion of a prototype extended-wear 12-lead ECG patch, a strategic collaboration with the Icahn School of Medicine at Mount Sinai to advance AI-enabled ECG algorithms, and the appointment of a new chief commercial officer to support growth initiatives.
The company's technology is designed to collect ECG signals in 3D from three non-coplanar directions and synthesize them into a 12-lead ECG, enabling portable devices that can be used wherever the patient is. This platform aims to help physicians identify cardiac health trends and acute conditions and direct patients to appropriate care outside of medical facilities.
HeartBeam's 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024, followed by the 12-lead ECG synthesis software clearance in December 2025. The company holds over 20 issued patents related to technology enablement. For more details, the full press release is available at https://ibn.fm/3KQqG.
About HeartBeam, Inc.: HeartBeam is a medical technology company dedicated to transforming the detection and monitoring of critical cardiac conditions. The company is creating the first-ever cable-free device capable of collecting ECG signals in 3D, from three non-coplanar directions, and synthesizing the signals into a 12-lead ECG. This platform technology is designed for portable devices that can be used wherever the patient is to deliver actionable heart intelligence.
Forward-looking statements in this article involve risks and uncertainties, including those set forth under "Risk Factors" in the company's most recent Annual Report on Form 10-K and other filings with the SEC. The latest news and updates relating to BEAT are available at https://ibn.fm/BEAT.
