BioMedNewsBreaks — HeartBeam Inc. (NASDAQ: BEAT) Earns FDA Clearance for First Cable-Free ECG System for Arrhythmia Detection
HeartBeam (NASDAQ: BEAT) announced it has received FDA 510(k) clearance for its flagship ECG system, a first-of-its-kind, credit card-sized, cable-free device designed to deliver high-fidelity, three-directional cardiac recordings for arrhythmia evaluation. The clearance marks a major regulatory milestone and accelerates HeartBeam’s plans to improve access to timely, remote cardiac care. When symptoms arise, patients use the app-guided system to record a 30-second ECG, which is automatically uploaded to the cloud for physician review in the context of medical history. The company will soon launch an Early Access Program to engage early adopters and providers ahead of broader commercialization. This foundational…