secwatch.observer — SEC 8-K summary
======================================

Issuer:     HeartBeam, Inc. (BEAT)
CIK:        0001779372
Form:       8-K
Filed at:   2025-11-21T23:59:59+00:00
Accession:  0001213900-25-113353
Event type: regulatory
Sentiment:  negative
Materiality: 0.75
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

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

- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1779372/000121390025113353/0001213900-25-113353-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1779372/000121390025113353/ea0266730-8k_heartbeam.htm
  HTML page:      https://secwatch.observer/filing/0001213900-25-113353

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer