LabStyle’s Dario glucose monitor wins FDA 510(k)

Diabetes focused mobile-health developer LabStyle Innovations said today it won FDA 510(k) clearance for its Dario blood glucose monitoring system, including its blood test strips and the Dario app for Apple (NSDQ:AAPL) iOS devices.

The system is designed to operate around a smartphone and a small glucose meter that communicates with the phone through the audio jack, the company said. The smartphone as a central device is important to the systems functionality and ease of adopting, executive veep Todd Durniak told MassDevice.com in an interview in September.

The small plug-in monitor contains everything necessary to take blood glucose readings, which the Dario platform uploads to cloud-based storage where they can be observed, recorded and shared by caretakers, physicians and others, Durniak said.

“We are very pleased and excited to receive the FDA’s marketing clearance for Dario. While Dario has already been approved in numerous countries throughout the world, the U.S. is the single largest market in the global blood glucose monitoring market. We believe sales in the U.S. will have a substantial impact on LabStyle’s financial performance and value,” CEO Erez Raphael said in prepared remarks.

Israel-based LabStyle Innovations said the Dario blood glucose monitoring system won indications for the “quantitative measurement of glucose in fresh capillary whole blood samples drawn from the finger tips.”

“Based on our experience in the markets where we’ve already launched, we believe Dario offers a superior user engagement when compared to alternative devices. We believe people in the U.S. will have a similarly favorable user experience. This is the core competitive advantage of Dario. Having received marketing clearance, we are now preparing for the imminent launch of Dario in the U.S. In the future we look forward to expanding the indications and platforms on which Dario will be used in the U.S.,” Durniak said in a press release.

In September, LabStyle Innovations said it raised $2.5 million in a new round of equity financing. The round was joined by private investors, including current shareholders, and a new investment from Shmuel Farhi, the company said.

The device received CE Mark approval in the European Union in 2013.

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