FDA Clearance for HeartBeam's 12-Lead ECG Software Marks Advancement in Remote Cardiac Monitoring

HeartBeam Inc. (NASDAQ: BEAT) was featured in a Modern Healthcare report by Lauren Dubinsky on January 8, highlighting recent FDA clearances and approvals in the medical device sector. The company's 12-lead electrocardiogram synthesis software received FDA clearance on December 8, enabling arrhythmia assessment by converting three-dimensional heart signal data captured from its portable, non-invasive recorder into a standard 12-lead ECG format suitable for remote clinical review. This development represents a significant step forward in making comprehensive cardiac diagnostics accessible outside traditional medical facilities.

The technological achievement is further validated by HeartBeam's recognition as a Global IP and Technology Leader in Portable Cardiac Diagnostics, where it ranked second worldwide behind only GE Healthcare in 12-lead ECG innovation. This ranking emerged from PatentVest's "Total Cardiac Intelligence" report, which evaluated 243 companies in the field. According to an InvestorBrandNetwork report, the company's strong intellectual property foundation includes 82 global patent publications across 15 patent families supporting its three-dimensional cardiac signal capture and 12-lead ECG synthesis architecture. This robust IP portfolio underscores HeartBeam's growing influence in next-generation remote cardiac monitoring solutions.

The FDA clearance enables HeartBeam's platform technology to deliver actionable heart intelligence through portable devices that can be used wherever patients are located. This capability allows physicians to identify cardiac health trends and acute conditions while directing patients to appropriate care outside medical facilities. The company's technology represents the first cable-free device capable of collecting ECG signals in three dimensions from three non-coplanar directions and synthesizing them into a 12-lead ECG. HeartBeam's 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024, with the 12-Lead ECG synthesis software following in December 2025.

For additional information about HeartBeam's technology and developments, visit https://heartbeam.com. The company maintains an active newsroom at https://ibn.fm/BEAT where investors can access the latest updates. BioMedWire, the specialized communications platform that published this information, provides comprehensive coverage of developments in biotechnology, biomedical sciences, and life sciences sectors as part of the Dynamic Brand Portfolio at IBN.