Ascensia gets FDA clearance for Contour Next One connected glucometer

By Jonah Comstock
04:00 pm

Ascensia Diabetes Care, a business unit created this year when Panasonic Healthcare Holdings acquired Bayer Diabetes Care, has received FDA clearance for a second connected glucometer device, the Contour Next One. Its previous device, the Contour Next Link, was cleared in August.

While the Contour Next Link was designed specifically to connect to a Medtronic insulin pump, the Contour Next One is aimed at a broader group of users. It connects via Bluetooth to the Contour Diabetes app, available on iOS and Android. On the app, users can log their diet and exercise as well as track trends in their blood glucose. They can send data to a care provider as a PDF, and deduce insights about their diabetes based on the various data streams.

"We believe the future of healthcare lies in connecting points of care," Robert Schumm, head of Ascensia Diabetes Care US, said in a statement. "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."

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As well as sending data to an app, a "smartLight" feature allows feedback, reminders, and alerts to be displayed on the meter itself. According to the company, in clinical trials, the meter returned 95 percent of results accurate within 8.4 mg/dL of laboratory reference values.

Ascensia plans to launch the platform in the US in early 2017, though the apps are already available from the iTunes and Google Play stores.


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