FDA Grants Clearance for LabStyle’s Blood Glucose Monitoring System

The FDA has granted clearance for LabStyle Innovations’ Dario blood glucose monitoring system.

The clearance also covers the system’s components, including the Dario blood glucose meter, Dario blood glucose test strips, Dario glucose control solutions and the Dario app on the Apple iOS 6.1 platform and higher.

Indicated for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, the system helps patients manage their diabetes using a smartphone.

According to LabStyle, unlike traditional systems, there is no carrying case or batteries to replace. — Michael Cipriano