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By: NewMediaWire
January 9, 2026

Curated TLDR

FDA Clearance for HeartBeam (BEAT) Highlighted in Medical Device Approvals Roundup

LOS ANGELES, CA - January 9, 2026 (NEWMEDIAWIRE) - HeartBeam (NASDAQ: BEAT) was among the medical device companies highlighted in a Jan. 8 report by Modern Healthcare by Lauren Dubinsky that outlined FDA clearances and approvals across the medical device sector. HeartBeam’s 12-lead electrocardiogram synthesis software was cleared Dec. 8 to assess arrhythmias by converting heart signal data captured from 3 dimensions using the company’s portable, non-invasive recorder into a standard 12-lead ECG format suitable for remote clinical review.

HeartBeam recently reinforced its technology leadership with recognition as a Global IP and Technology Leader in Portable Cardiac Diagnostics, ranking second worldwide and trailing only GE Healthcare, in 12-lead ECG innovation among 243 companies evaluated in PatentVest’s “Total Cardiac Intelligence” report, according to an InvestorBrandNetwork report. The ranking reflects the strength of its intellectual-property foundation, with 82 global patent publications across 15 patent families supporting its three-dimensional cardiac signal capture and 12-lead ECG synthesis architecture, underscoring the company’s growing influence in next-generation remote cardiac monitoring.

To learn more about Heartbeam’s Portable ECG Technology, visit https://ibn.fm/pfPB1

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 directions, 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 and the 12-Lead ECG synthesis software in December 2025. The Company holds over 20 issued patents related to technology enablement. For additional information, visit HeartBeam.com.

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

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