HeartBeam gets FDA NSE on ECG software 510(k), 3D ECG cleared

HeartBeam, Inc. reported that on November 20, 2025 it received a Not Substantially Equivalent (NSE) letter from the U.S. Food and Drug Administration regarding its 510(k) application for its 12-Lead Electrocardiogram (ECG) Synthesis Software.

Rhea-AI Filing Summary

HeartBeam, Inc. reported that on November 20, 2025 it received a Not Substantially Equivalent (NSE) letter from the U.S. Food and Drug Administration regarding its 510(k) application for its 12-Lead Electrocardiogram (ECG) Synthesis Software. An NSE letter means the FDA did not find the device substantially equivalent to a predicate device under this submission. The company stated that it stands behind its clinical data and plans to work with the FDA to reach a resolution. HeartBeam also noted it is evaluating the launch of its novel 3D ECG system, which previously received FDA 510(k) clearance in December 2024.

Positive

• None.

Negative

• FDA issues NSE letter on 510(k) ECG software, signaling a regulatory setback that may delay or complicate U.S. clearance for HeartBeam’s 12-lead ECG Synthesis Software.

Insights

Healthcare regulatory and medtech analyst

FDA’s NSE letter is a regulatory setback for HeartBeam’s ECG software.

The company disclosed that it received a Not Substantially Equivalent (NSE) letter from the FDA for its 510(k) application covering its 12-lead ECG Synthesis Software. An NSE outcome means the FDA, based on this submission, did not agree the software is substantially equivalent to a legally marketed predicate device, which can delay or complicate U.S. commercialization through this pathway.

HeartBeam emphasized that it stands behind its clinical data and intends to work with the FDA to find a resolution. The filing also highlights that the company is evaluating a launch of its novel 3D ECG system, which already has FDA 510(k) clearance from December 2024, indicating it does have at least one cleared product in its portfolio. The ultimate impact on growth will depend on whether and how the company can address the FDA’s concerns in future regulatory interactions.

8-K Event Classification

Item 8.01 — Other Events

1 item

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did HeartBeam, Inc. (BEAT) announce in this 8-K filing?

HeartBeam, Inc. reported that it received a Not Substantially Equivalent (NSE) letter from the FDA related to its 510(k) application for its 12-Lead Electrocardiogram (ECG) Synthesis Software, and noted it plans to work with the FDA toward a resolution.

What is the significance of the FDA Not Substantially Equivalent (NSE) letter for HeartBeam (BEAT)?

An NSE letter means the FDA did not find the device substantially equivalent to a predicate device under the current 510(k) submission, which represents a regulatory setback for HeartBeam’s 12-Lead ECG Synthesis Software.

How is HeartBeam responding to the FDA’s NSE decision on its 510(k) application?

HeartBeam stated that it stands behind its clinical data and will be working with the FDA to come to a resolution regarding the 12-Lead ECG Synthesis Software submission.

Does HeartBeam currently have any FDA-cleared products?

Yes. HeartBeam disclosed that its novel 3D ECG system received FDA 510(k) clearance in December 2024, and the company is evaluating launching this system.

Which product from HeartBeam (BEAT) received the NSE letter and which product is already cleared?

The 12-Lead ECG Synthesis Software received the NSE letter, while the company’s novel 3D ECG system previously obtained FDA 510(k) clearance in December 2024.

What type of SEC filing did HeartBeam use to disclose the FDA NSE letter?

HeartBeam disclosed the NSE outcome in a Form 8-K under Item 8.01: Other Events, which is used to report significant events to investors.

AI-generated analysis. How Rhea-AI works. Not financial advice.

Understanding 8-K Material Events →

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

Accepted by SEC EDGAR 11/21/2025 - 09:47 AM Learn about SEC filing dates

false 0001779372 0001779372 2025-11-20 2025-11-20 0001779372 us-gaap:CommonStockMember 2025-11-20 2025-11-20 0001779372 us-gaap:WarrantMember 2025-11-20 2025-11-20 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities and Exchange Act of 1934

Date of Report (Date of earliest event reported): November 20, 2025

HEARTBEAM, INC.

(Exact name of Registrant as specified in its charter)

Delaware		001-41060		47-4881450
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

2118 Walsh Avenue, Suite 210

Santa Clara, CA 95050

(Address of principal executive offices, including zip code)

(408) 899-4443

(Registrant’s telephone number, including area code)

Check the appropriate box below if the 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:

☐	Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)).

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock		BEAT		NASDAQ
Warrant		BEATW		NASDAQ

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ 

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.

1

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

2