Health Canada’s Therapeutic Products Directorate, the authority that regulates pharmaceutical drugs and medical devices in Canada, approved the sale of the Bluetooth-powered MyGlucoHealth system on Thursday, July 28, 2011.
MyGlucoHealth, created by Entra Health Systems, functions as a glucose meter that transmits test results to the patient’s phone wirelessly via Bluetooth.
To expand on this function, the developers of MyGlucoHealth have also created the MyGlucoHealth Patient Analytics Portal. This system allows patients and health care professionals to access the test data from a desktop computer, tablet, or mobile phone, establishing direct communication between the caregiver and patient.
MyGlucoHealth had already received FDA clearance in the US and a CE Mark in Europe and enjoyed a large-scale launch in Australia in 2009. Additionally, Entra has had what it refers to as “significant success” in the US and Asian Pacific with MyGlucoHealth.
However, this product marks a first for Canadian diabetes management, being the only Bluetooth-enabled blood glucose meter approved to attach directly to a mobile phone in Canada. Thus, the adoption of MyGlucoHealth marks the transition into a Canadian mobile healthcare that is powered by mobile phone add-ons and patient-caregiver communication.