HeartBeam receives FDA NSE letter for 12-Lead ECG Synthesis 510(k), will seek resolution

HeartBeam, Inc.

FDA issued a Not Substantially Equivalent (NSE) letter for HeartBeam's 12-Lead ECG Synthesis Software 510(k) on Nov 20, 2025.
Company stands behind its clinical data and will work with FDA to resolve the NSE determination.
HeartBeam is evaluating launching its 3D ECG system, which received FDA clearance in December 2024.
No financial impact or guidance change disclosed; product approval timeline uncertain.

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