Philosys has received an FDA 510(k) clearance for the Android version of its smart glucometer companion app, called Gmate Smart.
The device now works with Samsung Galaxy S3, S4, and S5 devices that have an Android operating system 4.0 or higher as well as Apple iPhone, iPod Touch, and iPad with iOS version 5.0 or higher. Philosys received an FDA clearance for the iOS app last year, in August, but...
New York City-based medical device maker Philosys received FDA 510(k) clearance this week for its smartphone-connected glucose meter, Gmate Smart.
To use the Gmate Smart glucometer, users launch the device's connected app, plug in their Gmate glucometer through the audio jack, insert a test strip into the glucometer, add a blood sample, and view results on the app. Gmate Smart's app is only...
New York City-based Philosys recently announced that it had received a European CE Mark for its Gmate Smart glucose meter, which connects to the iPhone and iPad via the devices' headphone jacks. Philosys noted that the CE Mark approval was a year in the making and so it aims to bring the device to market in Europe by the end of this year.
As Medgadget points out, since the device uses the Apple...
