FDA Clears DarioHealth’s Glucose Meter and App

July 25, 2017

DarioHealth announced it has secured 510(k) clearance for its combination glucose meter and app for Android devices from the FDA.

The pocket-sized meter device syncs with a companion app, available on Android and iOS devices, which includes a nutrition guide and log. Users can view all the raw data as well as patterns and trends in the data.

DarioHealth marketed the product in the United States exclusively for the Apple iOS 6.1 platform and higher since receiving FDA clearance in December 2015.

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