LOS ANGELES, CA - December 1, 2025 (NEWMEDIAWIRE) - HeartBeam (NASDAQ: BEAT), a medical technology company developing personalized cardiac-care insights, detailed its strategy following receipt of a Not Substantially Equivalent decision for its 510(k) submission covering its 12-lead ECG Synthesis Software. The Company has been in active discussions with FDA review staff, which have signaled willingness to work toward a constructive resolution. HeartBeam said its VALID-ECG clinical study met endpoints and that remaining FDA concerns may be resolved through revised labeling. To advance the process, the Company plans to pursue multiple parallel paths - including a formal appeal or a 510(k) resubmission - and believes recent interactions indicate a viable path forward under the appeal option, which carries an expected 60-day timeline. HeartBeam will continue providing updates on commercialization and funding plans as regulatory engagement progresses.

To view the full press release, visit https://ibn.fm/C381i

About HeartBeam, Inc.

HeartBeam, Inc. is a medical technology company dedicated to transforming the detection and monitoring of critical cardiac conditions. The Company is creating the first-ever cable-free device capable of collecting ECG signals in 3D, from three non-coplanar dimensions, and synthesizing the signals into a 12-lead ECG. This platform technology is designed for portable devices that can be used wherever the patient is to deliver actionable heart intelligence. Physicians will be able to identify cardiac health trends and acute conditions and direct patients to the appropriate care – all outside of a medical facility, thus redefining the future of cardiac health management. HeartBeam’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024. The Company holds over 20 issued patents related to technology enablement.

Please see full terms of use and disclaimers on the InvestorBrandNetwork website applicable to all content provided by IBN, wherever published or re-published: http://IBN.fm/Disclaimer

The latest news and updates relating to BEAT are available in the company’s newsroom at https://ibn.fm/BEAT

Forward Looking Statements

Certain statements in this article are forward-looking, as defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks, uncertainties, and other factors that may cause actual results to differ materially from the information expressed or implied by these forward-looking statements and may not be indicative of future results. These forward-looking statements are subject to a number of risks and uncertainties, including, among others, various factors beyond management's control, including the risks set forth under the heading "Risk Factors" discussed under the caption "Item 1A. Risk Factors" in Part I of the Company's most recent Annual Report on Form 10-K or any updates discussed under the caption "Item 1A. Risk Factors" in Part II of the Company's Quarterly Reports on Form 10-Q and in the Company's other filings with the SEC. Undue reliance should not be placed on the forward-looking statements in this article in making an investment decision, which are based on information available to us on the date hereof. All parties undertake no duty to update this information unless required by law.

This contant was orignally distributed by NewMediaWire. Blockchain Registration, Verification & Enhancement provided by NewsRamp™. The source URL for this press release is HeartBeam (BEAT) Outlines Regulatory Strategy After NSE Decision on ECG Synthesis Software.