FDA greenlights the Dario Blood Glucose Monitoring system

Dario Blood Glucose Monitoring system

LabStyle Innovations’ Dario Blood Glucose Monitoring System received FDA’s 510K clearance, and is now ready to be sold on the U.S. soil.

“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 U.S. is the single largest market in the global blood glucose monitoring market.” stated LabStyle Chairman and CEO Erez Raphael. “We believe sales in the U.S. will have a substantial impact on LabStyle’s financial performance and value.”

The Dario Blood Glucose Monitoring System consists of several 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.

The system helps people with diabetes monitor their blood sugar levels and proactively manages 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 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.

Users also get to benefit from 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 makes it easy for users to share health information with healthcare providers and loved ones.

Earlier this year, LabStyle Innovations raised $2.5 million to help with its global rollout of Dario and this FDA clearance is part of that (same) plan.