Ascensia Receives CE Mark For New Contour Blood Glucose Monitors


Ascensia Diabetes Care has received CE Mark for the new CONTOUR NEXT ONE and CONTOUR PLUS ONE blood glucose monitoring systems, which will allow Ascensia to market the new glucose meters in Europe.

Ascensia Diabetes Care was established in 2016 through the sale of Bayer Diabetes Care to Panasonic Healthcare Holdings Co., Ltd. Ascensia Diabetes Care products are sold in more than 125 countries. 

The CONTOUR NEXT ONE and CONTOUR PLUS ONE systems feature an easy-to-use wireless-enabled blood glucose smart meter that links to a smart 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 received from the meter. Blood glucose results can be analyzed for patterns and trends that may help patients understand how certain aspects of their daily activities affect their blood glucose.

According to the company the CONTOUR NEXT ONE and CONTOUR PLUS ONE meters have shown remarkable accuracy that exceeds the ISO 15197:2013 accuracy criteria in the laboratory and clinical setting. In a clinical study for CONTOUR NEXT ONE, 95% of meter results were within 8.4 mg/dL or 8.4% of the reference result for subject fingertip tests. In a similar CONTOUR™ PLUS ONE clinical study, 95% of meter results were within 8.5 mg/dL or 8.5% of the reference result for subject fingertip tests.

Features of the system include a smart light on the meter that gives instant feedback on blood glucose results, reminders and alerts to help support better management of diabetes, and an extensive electronic logbook that records events such as meals, activities and medication. Users can set-up an optional cloud account for management and storage of data and have the ability to email PDF summary reports to their healthcare professionals for discussion. 

The two meters and the CONTOUR Diabetes App will be launched initially in two European markets and later in 2016 across further European countries. CONTOUR NEXT ONE will be launched in countries where the CONTOUR NEXT test strips are already available and CONTOUR PLUS ONE will be launched where the CONTOUR™ PLUS test strips are available. The CONTOUR™ Diabetes App will be available in the Apple App Store (iOS) and Google Play (Android).

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