LabStyle Innovations files 510(k) with FDA for Dario Blood Glucose Monitoring System

Published on January 7, 2014 at 8:06 AM · No Comments

LabStyle Innovations Corp. (OTCQB:DRIO), developer of Dario™, a cloud-based, mobile health platform for diabetes and blood glucose monitoring, announced today that it has filed a Premarket Notification Application, also known as a 510(k), with the US Food and Drug Administration (FDA) for the Dario Blood Glucose Monitoring System.

"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," said LabStyle president and chief executive officer Erez Raphael. 

The complete Dario™ diabetes management platform combines the aforementioned all-in-one, blood glucose monitoring system, a smart phone application (iOS & Android), and a website application.

Dario is the first complete diabetes management platform designed to empower people with diabetes to take charge of their health with the right tools, insights, and support, right in their pocket.  With access to both real-time and historical blood glucose data, the Dario™ platform is designed to spot patterns, recommend the right treatments and support behavior change efforts. In the future, Dario™ will help doctors to better identify patients at high-risk, to make, more frequently, better and faster clinical decisions, and to more easily, routinely follow-up. The Dario™ platform is also expanding to assist health systems in automatically targeting resources to patients who are most likely to have acute or long-term complications.

Mr. Raphael continued, "I'd like to take this opportunity to thank our investors, partners, associates and the thousands living with diabetes worldwide who have heard our story for their continued enthusiasm and support.  We achieved great things at LabStyle in 2013, and we are continually working to put in place the pieces for future achievements and growth at the company. We would like to wish the entire Dario community and their families, a very happy, healthy and prosperous 2014."

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