Ascensia Diabetes Care has received 510(k) approval from the FDA for the Contour Next One Blood Glucose Monitoring System .
Ascensia Diabetes Care announced it has received FDA 510(k) clearance for the Contour Next One Blood Glucose Monitoring System (BGMS), marking a key step in making the next-generation system available to people living with diabetes in the U.S.
Ascensia Diabetes Care expects to make the Contour Next One system available in the U.S. in early 2017. The Contour Diabetes app will be available for download from the Apple App Store (iOS) and Google Play (Android).
The Contour Next One system features an easy-to-use blood glucose smart meter which links to a mobile device via Bluetooth connectivity. The meter connects to the Contour Diabetes app, a mobile app that collects, stores and analyzes patient blood glucose measurements delivered to it by the meter. The blood glucose measurements can be used to identify patterns and trends that may help patients understand how certain aspects of their daily activities affect their blood glucose.
Comment: The Contour Next One system has CE Mark approval.
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