CardioComm Solutions has received clearance from Health Canada for its HeartCheck ECG PEN for heart beat readings to both consumers and patients under physician prescription.
According to the company, the HeartCheck ECG PEN takes accurate heart readings anytime in only 30 seconds. It saves up to 20 heart rhythms, which can be downloaded and printed from a computer, or sent to a physician, clinic, or ECG coordinating centre.
The Health Canada license (89624) was granted 6 September 2012. The HeartCheck ECG PEN was first cleared for sale in the United States by the FDA as the HeartCheck PEN Handheld ECG with GEMS Home. The Health Canada approval now completes the ability for CardioComm Solutions to market their HeartCheck brand of handheld ECG devices across North America.
GEMS Home, the free downloadable, software designed by the CardioComm to provide a personal heart rhythm/ECG health record on a person’s home computer also provides connectivity between the HeartCheck PEN readings and CardioComm Solutions’ ECG coordinating centre known as C4. GEMS Home use is approved by Health Canada under the company’s existing GlobalCardio and GEMS clearances.
