Israel-based LabStyle Innovations announced CE mark certification for its smartphone-based glucose monitor Dario, according to a press release. In the coming months, the company will plan a soft launch of Dario in Europe to collect customer feedback and refine its roll-out strategy.
In May, LabStyle raised $10 million by common stock and planned to use the money to develop, market and manufacture Dario.
Because LabStyle now has CE mark certification, the company "plans to accelerate its ongoing efforts to prepare and file with the US Food and Drug Administration a 510(k) application for marketing approval of Dario in the United States." After that, LabStyle will approach regulatory programs in Asia and South America.
“The key target populations for Dario are type 1 diabetics as well as insulin-dependent type 2 diabetics, who represent 15 percent to 30 percent of the diabetic population and typically test themselves multiple times a day," LabStyle’s President and CEO Erez Raphael said in a press release. "...Our strategy is to commence an initial launch of Dario and gain critical feedback from the market, which we will use in tandem with our partners to further refine our design, marketing and intellectual property programs as we advance to full commercial sales over the next 12 months. Importantly, with CE mark in hand we look forward to accelerating our regulatory approval process in the US and elsewhere during the remainder of 2013.”
Dario is a small glucose meter which syncs with a companion app and works with Apple iPhone 5, iPads and iPods and Android devices like the Samsung Galaxy S4 and Tab. The app includes a nutrition guide, logbook, insulin calculator and monitoring system. A data overview within the app displays a radial chart of blood glucose measurements. It also shows how many measurements were above, below or within the blood glucose target range and if they were before or after a meal.
Another device similar to Dario, the iBGStar, has had FDA clearance since 2011. The device, which was AgaMatrix and Sanofi co-developed, was the first smartphone-enabled blood glucose meter to integrate directly with a smartphone. Unlike Dario, which will work with both iOS and Android, iBGStar only connects to Apple devices. In a recent interview, Sanofi UK's Brand Lead for blood glucose monitoring Jason Lovatt said the company had plans to expand its technology to Android.