---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-25-113353"
form_type: "8-K"
ticker: "BEAT"
cik: "0001779372"
company_name: "HeartBeam, Inc."
filed_at: "2025-11-21T23:59:59+00:00"
generated_at: "2026-05-16T17:40:16.861137+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001213900-25-113353
- form_type: 8-K
- ticker: BEAT
- cik: 0001779372
- company_name: HeartBeam, Inc.
- filed_at: 2025-11-21T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1779372/000121390025113353/0001213900-25-113353-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1779372/000121390025113353/ea0266730-8k_heartbeam.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-25-113353
- JSON: https://secwatch.observer/filing/0001213900-25-113353.json
- Plain text: https://secwatch.observer/filing/0001213900-25-113353.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.