mHealth: LabStyle's diabetes management device and mobile app lands E.U. approval

September 23, 2013 by Arezu Sarvestani

Israeli device maker LabStyle Innovations gains 4% on Wall Street today after announcing plans for "soft launch" of its Dario smartphone-based diabetes management system.

Smartphone diabetes management tool Dario lands E.U. approval

Two-year-old LabStyle Innovations Corp. (OTCQB:DRIO) made the shift from an R&D-stage company to a commercial enterprise with CE Mark approval in the European Union to market its smartphone diabetes management system, the Dario all-inclusive blood glucose monitoring device and mobile data management system.

The mobile app is also a stand-alone program that LabStyle plans to offer to users of other glucose monitors, according to a company statement. The device maker is also hoping to accelerate its FDA 510(k) submission efforts, after which LabStyle will focus on regulatory submissions in Asia and South America.

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News of the approval sent DRIO shares up nearly 4% in mid-morning trading, going for $2.80 as of about 11:40 a.m. today.

Israel-based LabStyle is planning a "soft launch" of the Dario system in the coming months, hoping to gather user feedback among European patients and to "refine its longer-term roll-out strategy."