Innovative Blood Glucose Monitoring System Approved

A smartphone-based blood glucose monitor with unique all-in-one design has been cleared for launch in the world's largest diabetes market.

The Blood Glucose Monitoring System is indicated for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The compact all-in-one system helps people with diabetes monitor their blood sugar levels and proactively manage their diabetes using their smartphone.

The Labstyle’s Dario Blood Glucose Monitoring System (Caesarea, Israel) 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 easy to carry device to take blood glucose measurements on the spot. Unlike conventional glucose monitors, there is no carrying case or batteries to replace. Dario provides real-time and historical blood glucose data to allow health care providers to spot patterns, recommend treatments and support behavior changes. Dario's web interface also makes it easy for users to share health information with healthcare providers and relatives.

The United States Food and Drug Administration (FDA; Silver Springs, MD, USA) 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. Erez Raphael, BA, the CEO and president of LabStyle Innovations Corp., that developed the Dario system, said, “We are very pleased and excited to receive the FDA's marketing clearance for Dario. While Dario has already been approved in numerous countries throughout the world, the USA is the single largest market in the global blood glucose monitoring market. We believe sales in the USA will have a substantial impact on LabStyle's financial performance and value.”

Related Links:
Dario
United States Food and Drug Administration