Ascensia Diabetes Care Receives FDA Clearance for the App-Enabled Contour®Next One Blood Glucose Monitoring System
PARSIPPANY, New Jersey, November 21, 2016 /PRNewswire/ --
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.
Robert Schumm, Head of Ascensia Diabetes Care US, said: "This is an innovative new option for people living with diabetes. The system combines the remarkable accuracy of the CONTOUR® NEXT ONE meter with the easy-to-use features of the CONTOURTM DIABETES app and is designed to provide insights that may help people manage their diabetes in a better way."
He added: "We believe the future of healthcare lies in connecting points of care. The first step in that journey for diabetes is to provide a connected system which can add value for people living with diabetes. Today, fewer than two percent of people living with diabetes use a connected meter. CONTOUR® NEXT ONE is designed to be simple-to-use, and can meet the needs of a broad group of users. The FDA clearance paves the way to providing this option for all those who may benefit from it."
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). CONTOUR® NEXT ONE is the most accurate system developed by Ascensia Diabetes Care, shown to deliver remarkable accuracy, with 95% of results within ±8.4 mg/dL or ±8.4% of the laboratory reference values for glucose concentrations < 100 mg/dL or ? 100 mg/dL, respectively, when tested via subject obtained fingerstick results.1
The system features include a smartLIGHT on the meter which provides instant feedback on blood glucose results, reminders and alerts to help support better management of diabetes, and a simple but thorough electronic logbook where an individual can record events such as meals, activities and medication. Users can set-up an optional secure online, cloud-based account for the management and storage of their data, and have the ability to email PDF summary reports to their caregiver or healthcare professional for discussion.
Notes for Editors
About Ascensia Diabetes Care
Ascensia Diabetes Care is a global specialist diabetes care company, dedicated to helping people living with diabetes. Our mission is to empower people living with diabetes through innovative solutions that simplify and improve their lives. We use our innovation and specialist expertise in diabetes to develop high quality solutions and tools that make a positive, daily difference for people with diabetes.
Home to the world renowned CONTOUR® portfolio of blood glucose monitoring systems, our products combine advanced technology with user-friendly functionality that help people with diabetes to manage their condition. We are committed to continued research, innovation and development of new products and solutions. As a trusted partner in the diabetes community, we collaborate closely with healthcare professionals and other partners to ensure our products meet the highest standards of accuracy, precision and reliability, and that we conduct our business compliantly and with integrity.
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. Following the close of the transaction in all countries, Ascensia Diabetes Care will have around 1,700 employees and operations in 38 countries.
For further information please visit the Ascensia Diabetes Care website at: http://www.ascensia.com.
© 2016 Ascensia Diabetes Care. Ascensia and Contour are trademarks and/or registered trademarks of Ascensia Diabetes Care. The Bluetooth word mark and logos are registered trademarks owned by Bluetooth SIG, Inc., and any use of such marks herein is under license.
Apple and the Apple logo are trademarks of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc. Google Play is a trademark of Google Inc.
1 Christiansen M et al. Accuracy and User performance Evaluation of a New Blood-Glucose Monitoring System in development for use with CONTOUR®NEXT Test Strips. Poster presented at the 15th Annual Meeting of the Diabetes Technology Society (DTS); 22-24 October, 2015; Bethesda, Maryland.
For further information please contact: Joseph Delahunty FTI Consulting firstname.lastname@example.org Tel: +44 (0)20-3727-1000
SOURCE Ascensia Diabetes Care