The purpose of this study was to evaluate whether the 12-lead ECG could be substituted by ECG sets with a limited number of leads. Materials and methods: The performance of three ECG systems (ie ...
As noted above, the precordial leads are unreliable, compromising by their inclusion calculations deriving from the set of 12 ECG leads. It appears, therefore, that using sums of data from the six ...
The Company believes the study's findings support the clinical equivalence of HeartBeam's synthesized 12-lead ECG where the leads are similar to standard 12-lead ECGs for rhythm and arrhythmia ...
The FDA submission is backed by robust data from the VALID-ECG pivotal study, which enrolled 198 patients across five clinical sites. The Company believes the study's findings support the clinical ...