Unapproved Devices

Patients may ask about devices they see advertised online, and sold in other countries. Patients might order one of these devices, even though not approved by Health Canada. Note that you can search to find devices that do have Health Canada approval by going to the “Medical Devices Active License Listing (MDALL)” at https://health-products.canada.ca/mdall-limh/index-eng.jsp or by phoning 613-954-6790. If asked about unapproved medical devices we encourage you to consider the following:

 

  • Caution should be advised for medical devices that do not have Health Canada approval for overall quality and safety concerns. (Additionally, patients may not be able to load the associated app on their smart phone.)
  • Caution should be advised with using devices from other countries, since glucose (and therefore, insulin sensitivity factor) may not be measured in mmol/L as it is in Canada.

 

Examples of devices encountered by providers in the Calgary area:

HELO Extense

A non-invasive glucose meter using light to measure glucose levels in a person's finger (available on-line). Not approved by Health Canada. The company is not seeking approval from Health Canada. In the countries where it is approved, it is not indicated in type 1 diabetes and does not give results accurate enough to allow for medical management.

Miao Miao

A smart reader that fits over the Libre sensor, to send readings via Bluetooth to a smart phone. Not approved by Health Canada.