HeartBeam’s synthesised 12-lead electrocardiogram (ECG) has met the clinical endpoints in the VALID-ECG pivotal study, assessing non-life-threatening arrhythmias.
In the study, the mean difference in ECG intervals and amplitude between the company’s ECG and the standard 12-lead ECG was assessed.
Findings highlight a 93.4% diagnostic agreement, suggesting that HeartBeam's system is comparable to traditional 12-lead ECGs in diagnosing arrhythmias.
The multicentre study enrolled 198 subjects across five US clinical sites, including Mount Sinai Hospital, Atlanta Heart Specialists, Allegheny Health Network, Piedmont Heart Institute, and Northwell Health.
HeartBeam CEO Robert Eno said: "This important milestone successfully confirms that our novel technology can deliver diagnostic insights similar to a standard 12-lead ECGs for arrhythmia assessment.
“The ability to deliver 12-lead ECG-like data through a credit card-sized device that patients can use whenever and wherever arrhythmia symptoms occur underscores our long-term vision of bringing advanced cardiac health insights beyond medical facilities to improve patient outcomes.”
In January 2025, HeartBeam rolled out an application for its 12-lead ECG synthesis software to the US Food and Drug Administration (FDA), based on the data from this study.
In anticipation of FDA clearance, the company has initiated an early access programme to gather feedback on clinical workflows and prepare for US commercialisation.
The company noted that its patented three-dimensional ECG technology captures the electrical signals of the heart from three non-coplanar directions.
These signals are then synthesised into a 12-lead ECG using a transformation matrix.
HeartBeam's platform technology is tailored for portable devices used by individuals anywhere to deliver actionable heart intelligence.
Healthcare providers can guide their patients to the appropriate care outside of medical facilities by detecting acute heart conditions and health trends.
HeartBeam's 3D ECG technology received FDA clearance for arrhythmia assessment in December last year.
Last week, HeartBeam partnered with AccurKardia to enhance cardiac monitoring solutions’ accessibility.
