HeartBeam was highlighted in a Modern Healthcare report by Lauren Dubinsky that outlined recent FDA clearances and approvals across the medical device sector. The company's 12-lead electrocardiogram synthesis software received FDA clearance on December 8 to assess arrhythmias by converting heart signal data captured from three dimensions using the company's portable, non-invasive recorder into a standard 12-lead ECG format suitable for remote clinical review.
The FDA clearance represents a significant milestone for HeartBeam's technology, which is designed to transform 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.
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. 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.
This technological advancement underscores the company's growing influence in next-generation remote cardiac monitoring. 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, potentially 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 followed in December 2025.
The company holds over 20 issued patents related to technology enablement, demonstrating a robust intellectual property portfolio that supports its innovative approach to cardiac diagnostics. For additional information about HeartBeam's technology, visit https://ibn.fm/pfPB1. The latest news and updates relating to BEAT are available in the company's newsroom at https://ibn.fm/BEAT.
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