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 ...
Kardia 12L, a battery-operated, pocket-sized system, weighs just 0.3 lbs and uses just one cable with a reduced lead set. It features just five electrodes, halving the standard 10 electrodes ...
The device requires minimal self-guided training and is simpler and faster to use than standard 12-lead ECG machines. These features put 12-lead ECG data within reach of more healthcare providers ...
The study aimed to demonstrate the clinical equivalence of HeartBeam's synthesized 12-lead ECG to standard 12-lead ECGs for rhythm and arrhythmia assessment. HeartBeam's technology, which has ...
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