Ascensia Diabetes Care said today that it won FDA 510(k) clearance for its Contour Next One blood glucose monitoring system.
The connected system features a blood glucose meter that links to mobile devices using Bluetooth through the Contour Diabetes app. The app can collect, store and analyze the patient’s blood glucose measurements for patterns and trends to help patients understand how their everyday activities affect their blood glucose levels.
The Parsippany, N.J.-based company anticipates that the Contour Next One system will be available in the U.S. at the start of 2017.
Users can set up a cloud-based account to manage and store their data and can also email PDF summary reports to their healthcare professional. The system can remind and alert users to help support better management of diabetes, including an electronic logbook where a patient can record events such as meals and medication.
“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 Contour Diabetes app and is designed to provide insights that may help people manage their diabetes in a better way,” head of Ascensia Diabetes Care U.S. Robert Schumm said in prepared remarks. “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 2% 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.”
