FDA grant 510(k) approval for Dario Blood Glucose Monitoring System in type 2 diabetes- LabStyle Innovations
LabStyle Innovations has announced that the FDA has granted 510(k) clearance for the Dario Blood Glucose Monitoring System, including its components, 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.
The Dario Blood Glucose Monitoring System is indicated for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The system helps people with diabetes monitor their blood sugar levels and proactively manages their diabetes using their smartphone. Dario connects via a headphone jack to turn a mobile device into a glucose monitor, and incorporates a lancing device and test strips together with the meter in an all-in-one device to take blood glucose measurements on the spot. It also provides real-time and historical blood glucose data to allow health care providers to spot patterns, recommend treatments and support behavior changes.
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