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anhtong replied to the topic Discussion Topic: Android app for measuring blood glucose in the forum Regulatory Basics for Medical Devices 7 years, 9 months ago
I Found that:
Ascensia Diabetes Care announced it has received U.S. Food and Drug Administration (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.
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 CONTOURTM 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.