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FAQ: HeartBeam's FDA-Cleared 12-Lead ECG Technology and Industry Recognition
TL;DR
HeartBeam's FDA-cleared 12-lead ECG software offers a competitive edge in remote cardiac monitoring with strong IP ranking second globally behind GE Healthcare.
HeartBeam's software converts 3D heart signal data from a portable recorder into standard 12-lead ECG format for remote arrhythmia assessment.
This technology enables portable cardiac monitoring outside medical facilities, improving access to care and potentially saving lives through early detection.
HeartBeam holds 82 global patents across 15 families for its innovative 3D cardiac signal capture and ECG synthesis technology.
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HeartBeam was highlighted in a Modern Healthcare report for receiving FDA clearance for its 12-lead electrocardiogram synthesis software on December 8, 2025, which converts 3D heart signal data into standard 12-lead ECG format for remote arrhythmia assessment.
HeartBeam received FDA clearance for its 12-lead ECG synthesis software that converts 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 of arrhythmias.
The 12-lead ECG synthesis software received FDA clearance on December 8, 2025, while the company's 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024.
HeartBeam is creating the first-ever cable-free device capable of collecting ECG signals in 3D from three non-coplanar directions and synthesizing them into a 12-lead ECG, designed for portable use wherever the patient is located.
HeartBeam was recognized as a Global IP and Technology Leader in Portable Cardiac Diagnostics, ranking second worldwide (trailing only GE Healthcare) in 12-lead ECG innovation among 243 companies evaluated in PatentVest's 'Total Cardiac Intelligence' report.
HeartBeam has 82 global patent publications across 15 patent families supporting its three-dimensional cardiac signal capture and 12-lead ECG synthesis architecture, with over 20 issued patents related to technology enablement.
This technology enables physicians to identify cardiac health trends and acute conditions and direct patients to appropriate care outside of medical facilities, potentially redefining the future of remote cardiac health management.
You can visit https://ibn.fm/pfPB1 to learn more about HeartBeam's Portable ECG Technology or visit HeartBeam.com for additional company information.
This information was reported in a January 8, 2026, Modern Healthcare article by Lauren Dubinsky that outlined FDA clearances and approvals across the medical device sector, and was also covered by InvestorBrandNetwork.
HeartBeam, Inc. is a medical technology company dedicated to transforming the detection and monitoring of critical cardiac conditions through portable 3D ECG technology that delivers actionable heart intelligence outside of medical facilities.
Curated from NewMediaWire
