The Share system has been classified as a novel but low-to-moderate risk device, exempt from the requirement for premarket submissions.
The FDA has approved the first-ever system of mobile medical apps that allow real-time data to be shared between a continuous glucose monitor and mobile devices such as an Apple iPhone.
The Dexcom Share Direct Secondary Displays system is the first wireless device that allows caregivers or other designated "followers" to remotely monitor glucose levels of a person with diabetes.
"This innovative technology has been eagerly awaited by the diabetes community, especially caregivers of children with diabetes who want to monitor their glucose levels remotely," Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, said in a statement.
Link to the complete article on Medscape: http://bit.ly/1CoSOkp