LabStyle Innovations Corp., developer of the Dario Diabetes Management Solution, announced that the United States Food and Drug Administration (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 (sugar) 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 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 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 loved ones,
“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 US is the single largest market in the global blood glucose monitoring market,” stated LabStyle chairman and CEO Erez Raphael. “We believe sales in the US will have a substantial impact on LabStyle’s financial performance and value.”
“Based on our experience in the markets where we’ve already launched, we believe Dario offers a superior user engagement when compared to alternative devices. We believe people in the U.S. will have a similarly favorable user experience. This is the core competitive advantage of Dario,” added Todd Durniak, LabStyle’s executive vice president and general manager for the US.
“Having received marketing clearance, we are now preparing for the imminent launch of Dario in the US.”
“In the future we look forward to expanding the indications and platforms on which Dario will be used in the US,” Durniak added.
