LabStyle Innovations, a medical technology company based in Israel, won FDA clearance for its Dario glucose monitoring system.
LabStyle Innovations has received the United States Food and Drug Administration (FDA) approval for the Dario Blood Glucose Monitoring System. The system includes the Dario Blood Glucose Meter, Dario Blood Glucose Test Strips, Dario Glucose Control Solutions and the Dario app.
‘LabStyle Innovations has received the United States Food and Drug Administration (FDA) approval for the Dario Blood Glucose Monitoring System.’
"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."
"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 U.S. "Having received marketing clearance, we are now preparing for the imminent launch of Dario in the U.S."
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.