US-based LabStyle Innovations has obtained CE Mark approval for its Dario smartphone-based glucose monitor and comprehensive diabetes management system.
Particularly useful for insulin-dependent patients, the system provides patients, caregivers and clinicians both real-time and historic data with the goal of better management of blood glucose levels and improved health.
With this CE Mark approval, the company can now sell and market the Dario, a comprehensive system that combines an all-in-one self-monitoring of blood glucose (SMBG) device with a smartphone application and internet-based data services, in 32 countries across Europe as well as in certain other countries worldwide.
Dario app also includes a data log for blood glucose, food intake, insulin recommendation and analysis, and data sharing tools.
LabStyle Innovations plans to begin initial European soft launch of Dario in the coming months, with the goal of collecting customer feedback to refine its longer-term roll-out strategy, and further the company is expected to make available the Dario app to non-Dario device users in Europe in the near future.
The company now plans to file a 510(k) application with the US Food and Drug Administration for marketing authorization in the US.