(RTTNews) - HeartBeam, Inc., (BEAT), a medical technology company, Tuesday said its synthesized 12-lead electrocardiogram (ECG) met the clinical endpoints in the VALID-ECG pivotal study.
The study evaluated the mean difference in ECG intervals and amplitudes between HeartBeam's synthesized 12-lead ECG and simultaneously collected standard 12-lead ECG. Data from the study showed a 93.4% overall diagnostic agreement, indicating that HeartBeam's synthesized 12-lead ECG can support diagnosis of arrhythmias in a manner consistent with standard 12-lead ECGs.
"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," said Robert Eno, Chief Executive Officer, HeartBeam.
The company plans to initiate commercialization upon receiving FDA clearance for the 12-lead ECG synthesis software.
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