Software solutions provider CardioComm Solutions has received clearance from Health Canada to sell and market its HeartCheck ECG pen to both consumers and patients under physician prescription across Canada.
The company has translated the language to meet Health Canada requirements for consumer product sales through the assistance of Lionbridge Technologies and modified the original Health Canada application to include the OTC version of the HeartCheck pen.
The HeartCheck ECG PEN was first cleared for sale in the US by the FDA as the HeartCheck pen Handheld ECG with GEMS Home.
GEMS Home is a free downloadable software designed by the company to provide a personal heart rhythm/ECG health record on a person's home computer and also provides connectivity between the HeartCheck pen readings and the company's ECG coordinating centre known as C4.
CardioComm Solutions CEO Etienne Grima said, "All clearances were secured with only a short delay from the date of submission, with this final pair occurring in less than two months and today's fall in line with CardioComm Solutions' co-ordinated North American launch strategy for sale of both the locked (unlockable) and unlocked (ECG displaying) versions of the HeartCheckTM ECG PEN services."
CardioComm Solutions Board of Directors chairman Anatoly Langer said, "We have gone on record stating that CardioComm Solutions is committed to establishing a successful and innovative line of 'connected health' products to enable consumers and patients to put their heart health into their own hands and enable easier and more cost effective telemedicine and remote monitoring solutions for prescribed services as well as for self monitoring initiatives."
CardioComm Solutions Board of Directors member Simi Grosman said,"Our plans remain on track for the North American launch of the HeartCheckTM PEN and SMART Monitoring service, as well as for the development of a global distribution network."
