UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 8.01: Other Events
On November 20, 2025, HeartBeam, Inc. (the “Company”) received a Not Substantially Equivalent (NSE) letter from the U.S. Food and Drug Administration (FDA) related to the Company’s 510(k) application for its 12-Lead Electrocardiogram (ECG) Synthesis Software.
The Company stands behind its clinical data and will be working with the FDA to come to a resolution.
In addition, the Company is evaluating launching its novel 3D ECG system, which received FDA 510(k) clearance in December 2024.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
| HeartBeam, Inc. | ||
| Date: November 21, 2025 | By: | /s/ Timothy Cruickshank |
| Name: | Timothy Cruickshank | |
| Title: | Chief Financial Officer | |
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