Philosys recieves FDA clearance for smartphone-connected glucometer

August 27, 2014 | Reply More

Gmate Smart device and app | Credit: MobiHealthNews

Medical device maker Philosys recently recieved FDA 510(k) clearance for Gmate Smart, its smartphone-connected glucose meter. The glucometer connects to users smartphones through the audio jack– users merely need to launch the device’s connected app, insert a test strip into the device, and view results on their smartphone. Currently, Gmate Smart’s app is only compatible with iOS devices. The app also offers a note-taking and logging feature, where users can add notes to accompany their readings (including nutrition and fitness data or medication information) and review past readings and notes.

Philosys has already started preorders on the device to various retailers and insurance plans and will likely be sold at pricepoints ranging from $8.95 to $19.95, according to Philosys senior VP of sales Mike Tickle. Philosys also hopes to one day bring the device’s data into the cloud, allowing users to easily share their information with clinicians and caregivers.

Similar devices include Sanofi’s iBGStar, which uses iPhone’s dock connectors to sync with its glucometer, recieved its first FDA 510(k) clearance in December 2011; and Dario by LabStyle Innovations, which is still working towards receiving FDA clearance. Glooko also offers a cable that connects some of the most widely used off-the-shelf glucometers to smartphones in order to view and record readings.

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