HeartBeam (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through personalized insights, received FDA 510(k) clearance for its 12-lead ECG synthesis software for arrhythmia assessment after successfully appealing a prior NSE determination. The patented cable-free technology captures cardiac electrical signals in three non-coplanar dimensions to generate a synthesized 12-lead ECG that can be reviewed remotely by a board-certified cardiologist, enabling patients to capture meaningful ECG data wherever symptoms occur. With clearance in hand, HeartBeam plans a limited U.S. launch in early 2026 with select cardiology groups, alongside advancing programs in heart attack detection, development of an on-demand 12-lead extended wear patch, and the creation of AI-powered screening and prediction algorithms driven by longitudinal data from its 3D ECG platform.
NOTE TO INVESTORS: The latest news and updates relating to BEAT are available in the company’s newsroom at https://nnw.fm/BEAT
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer