LabStyle Innovations has received 510(k) approval from the US Food and Drug Administration (FDA) for its Dario blood glucose monitoring system.
The approval was also granted for the system’s components, including Dario blood glucose meter, Dario blood glucose test strips, Dario glucose control solutions and Dario app on the Apple iOS 6.1 platform.
LabStyle Innovations chairman and CEO Erez Raphael said: "While Dario has already been approved in numerous countries throughout the world, the US is the single largest market in the global blood glucose monitoring market.
"We believe sales in the US will have a substantial impact on LabStyle’s financial performance and value."
LabStyle has developed Dario for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The compact all-in-one system enables diabetes patients to monitor their blood sugar levels, helping to proactively manage diabetes using smartphone.
Dario will be connected through a headphone jack to turn a mobile device into a glucose monitor. It integrates 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.
According to the company, Dario offers real-time and historical blood glucose data to enable health care providers to spot patterns, recommend treatments and support behavior changes.
In September 2013, the firm obtained CE mark approval for Dario to market it in the European countries.