HeartBeam Wins FDA Clearance for At-Home Cable-Free 12-Lead ECG System

Reuters12-10

HeartBeam Wins FDA Clearance for At-Home Cable-Free 12-Lead ECG System

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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Heartbeam Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251210410973) on December 10, 2025, and is solely responsible for the information contained therein.

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