QT Medical Gets Expanded FDA Clearance for PCA 500

QT Medical has received an expanded FDA clearance for its PCA 500 electrocardiogram for pediatric patients including newborns.

Previously cleared for adult patients 18 years and older, the PCA 500 is a 12-lead resting electrocardiogram that includes a compact recorder.

PCA 500, which offers cloud-based ECG management, can be used as an at-home screening device by telehealth practices as well as in pediatric clinical trials.

QT Medical plans on presenting PCA 500 to the pediatric market at the 2022 American Academy of Pediatrics National Conference in Anaheim, Calif., Oct. 7-11.