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Approved in Israel, Dario All-in-One Smart Phone Glucose Meter Seeking FDA Nod


Israel’s LabStyle Innovations Corp. the developer of the Dario™ Diabetes Management Solution, announced this week that it has received approval from the Israeli government for the marketing and sale of the Dario™ Smart Meter in Israel.

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Dario is the world’s first personalized smart meter designed for use by diabetics. Dario combines a compact all-in-one glucose meter that plugs directly into a smart mobile device with personalized information and community support.

Dario is already available for use in the United Kingdom, Italy, and New Zealand where the initial market launch of the iOS version began in late March, 2014.

In 2013, LabStyle received CE Mark approval for the marketing and approval of the Dario system.

It is a cloud based, diabetes management solution, which includes novel software applications combined with the stylish, all-in-one, pocket-sized, Dario Smart Meter that interfaces with a user’s mobile device. A diabetic can get his or her glucose reading with the app as the results are simultaneously loaded onto the cloud.

Dario offers insulin dependent diabetics an alternative to the more cumbersome, standalone SMBG test kits that are the current market standard. In addition, Dario will provide patients, caregivers and clinicians both real-time and historic data with the goal of better management of blood glucose levels and improved health.

Earlier this year, LabStyle announced that it filed a 510(k) application with the US Food and Drug Administration (FDA) to allow for the marketing of Dario in the US.

The demand for the Dario Smart Meter has been very encouraging during the initial soft launch. In addition to its launch locations, LabStyle plans to be marketing Dario in 6 additional territories by the end of 2014.

Erez Raphael, LabStyle’s President and CEO, said “It has been very rewarding to experience the initial market demand for Dario™ in our soft launch territories, and we are proud of our achievements, including achieving regulatory approval in the country where the idea for Dario was born. The response in the select launch countries has been incredible and beyond our expectations. We are looking forward to bringing Dario to the population of people with diabetes here in Israel in order to help make their lives simpler by easily tracking their blood sugar changes and providing them with control and greater insights into their daily decisions for treating their chronic condition. “



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