HeartBeam, Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its cable-free synthesized 12-lead electrocardiogram $(ECG)$ software designed for at-home arrhythmia assessment. This decision follows a successful appeal of a previous Not Substantially Equivalent (NSE) determination. The patented technology enables patients to capture a comprehensive 12-lead ECG from home, with results reviewed by an on-demand, board-certified cardiologist. HeartBeam plans to initiate a limited market launch in early 2026, targeting select concierge and preventive cardiology groups to validate real-world performance before broader commercialization. No other organizations are mentioned as recipients of this regulatory clearance.