LabStyle Innovations files for FDA clearance of Dario glucose system

The developer of an all-in-one glucose monitoring system, including a blood glucose monitoring system, smartphone application and a website application, announced that it has filed a premarket notification application with the FDA, according to a press release.

Dario (LabStyle Innovations Corp.) has been designed to identify patterns, recommend the best treatment option and support change, according to the press release.

The company also plans to expand the platform’s use to assist health systems in automatically targeting resources to patients who have a greater risk for acute or long-term complications associated with diabetes.

“We are right on schedule, according to our previously announced plans. We have filed the 510(k) with the FDA in the United States for the Dario blood glucose monitoring system, one of three key components of the complete platform. The system includes: the dongle, the lancing device, the software application that shows the glucose level from the Dario dongle, the test strips, the check strip, the control solutions and lancets. Meanwhile, we are continuing our world rollout of Dario throughout Europe and the South Pacific. We are looking forward to achieving other milestones for LabStyle in 2014,” Erez Raphael, LabStyle president and CEO, said in the press release.

The first market launch of Dario began Dec. 12 in the United Kingdom, Australia and New Zealand.