Israel-based LabStyle Innovations 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.
The Dario glucose measurement system includes a dongle, a lancing device, and a software application that shows the glucose level from the Dario dongle, the test strips, the check strip, the control solutions and lancets.
The complete Dario diabetes management platform combines the all-in-one, blood glucose monitoring system, with a smartphone application (iOS and Android), and website function.
The diabetes management platform received CE mark certification in September 2013 and LabStyle launched the product in select countries in December 2013.
Dario is reportedly 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 from a pocket-sized device.
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 future, Dario would 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, according to the company.
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.
LabStyle president and CEO Erez Raphael said: "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. We are looking forward to achieving other milestones for LabStyle in 2014."
LabStyle began the worldwide roll-out of the Dario diabetes management platform with the market launch of the Dario iOS app in the UK, Australia and New Zealand.
The Dario iOS app is now available in these countries for free download at the Apple app store.
The company expects to launch the Dario iOS app in Italy and Belgium and the Dario Android app, in the UK, New Zealand, Australia, Italy and Belgium, during first quarter of 2014.
Plans are also on-track to soft launch the Dario all-in-one blood glucose monitoring device in the UK and Italy during the same time period.
The company is currently pursuing patent applications in multiple areas covering the specific processes related to blood glucose level measurement, as well as more general methods of rapid tests of body fluids using mobile devices and cloud-based services.
According to GlobalData estimates, the glucose monitoring market in the US was valued at $4.4bn in 2012 and is expected to grow at a CAGR of 4.3% to reach $5.94bn by 2019.
Image: Dario blood glucose monitoring system Photo: courtesy of LabStyle Innovations Corp./ Business Wire.