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

January 9, 2026 14:06:49

✎ Contributed by Ty Griffin

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.

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

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