Abbott’s continuous glucose monitoring system, the FreeStyle Libre 2, has been approved in Canada for adults and children four years and older with diabetes.
The FreeStyle Libre 2 system continuously measures glucose data every minute and can automatically alert users when their glucose is high or low without needing to scan the sensor.
It is worn on the back of the user’s upper arm for up to 14...
ECG, eh? The Apple Watch Series 4’s ECG and irregular heart rhythm notification functions have received approval from Canada’s health product regulator, according to listings on Health Canada’s website that were recently spotted by iPhone in Canada. With these in hand, its likely that devices owners living in the Great White North will soon have access to features that have so far been activated...
Entra Health Systems, creator of MyGlucoHealth, announced last week that it has received Health Canada's Therapeutic Products Directorate (TPD) clearance for the sale of its Bluetooth-enabled glucose meter in the country. MyGlucoHealth meters and test strips will be available for purchase in Canada immediately. The device secured FDA clearance and a CE Mark in 2009. MyGlucoHealth also launched...
The FDA cleared Abbott's i-STAT 1 Wireless point-of-care blood analyzer last week, marking the fourth wireless-enabled medical device to receive FDA clearance so far this year. Ascom, Monica Healthcare and Mobisante have each received a 510(k) clearance this year for a connected medical device. The FDA has cleared more than a dozen software apps for mobile devices over the years including one...
Last month when BlackBerry-maker Research In Motion officially launched its long awaited tablet, PlayBook, we noted the multiple hattips that RIM gave the medical community during the launch. For example, on-stage at the launch event for PlayBook, TouMetis CEO and President Mark Willnerd showed off a medical app that displayed patient data for orthopedic surgeons who could use the app to design...
FDA and Health Canada recently cleared Calgary Scientific's Resolution MD app, the system is certified for clinical use by Health Canada and the FDA. The smartphone application is offered free of charge to doctors who are affiliated with hospitals and diagnostic labs that implement the solution.
Update: The company is still seeking FDA approval for the app for handheld devices. A report over at...
