US-based LabStyle Innovations has filed 510(k) premarket notification application with the US Food and Drug Administration (FDA) for its Dario blood glucose monitoring system.
Dario is a cloud-based diabetes management platform which includes a blood glucose monitoring system, iOS and Android apps and a web application.
Dario is designed to help type 1 and insulin-dependent type 2 diabetic patients. The all-in-one device contains a lancet to obtain a small drop of blood, a strip dispenser and a glucose reader adaptor to hold the strip and interface with a smartphone.
According to the company, Dario is the first complete diabetes management platform that empowers diabetes patients to take charge of their health with the right tools, insights, and support, right in their pocket.
The Dario platform enables patients, medical professionals and caregivers to access and analyze both real-time and historical blood glucose data. It is designed to spot patterns, recommend the right treatments and support behavior change efforts.
LabStyle Innovations president and CEO Erez Raphael noted the company is right on schedule, according to its 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," Raphael added.
LabStyle Innovations received CE Mark approval for Dario in September 2013 and began its world rollout in select countries in December 2013. The company also launched the Dario iOS app in the UK, Australia and New Zealand in December 2013.
The company is planning to launch the Dario iOS app in Italy and Belgium during the first quarter of 2014, and Dario Android app in the UK, New Zealand, Australia, Italy and Belgium during the same period.
LabStyle Innovations also plans to soft launch the Dario all-in-one blood glucose monitoring device in the UK and in Italy during the first quarter of 2014.
Image: LabStyle Innovations’ Dario blood glucose monitoring system. Photo: Courtesy of BusinessWire/LabStyle Innovations Corp.