HeartBeam Receives FDA NSE Letter for 12-Lead ECG Synthesis Software

Reuters11-21

HeartBeam Receives FDA NSE Letter for 12-Lead ECG Synthesis Software

HeartBeam Inc. announced that it received a Not Substantially Equivalent (NSE) letter from the U.S. Food and Drug Administration (FDA) regarding its 510(k) application for its 12-Lead Electrocardiogram $(ECG)$ Synthesis Software. The company stated it stands behind its clinical data and plans to work with the FDA to resolve the issue. Additionally, HeartBeam is considering launching its novel 3D ECG system, which previously received FDA 510(k) clearance in December 2024.

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 EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001213900-25-113353), on November 21, 2025, and is solely responsible for the information contained therein.

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