The Israeli AMAR is a unit in the Ministry of Health and is responsible for certification of all activities concerning medical devices import, sale and export and is a precondition for the sale of medical devices in Israel.
AMAR approval will allow people with diabetes in Israel to soon join the initial Dario™ users in the United Kingdom, Italy, and New Zealand where the initial market launch of the iOS version of Dario™ began in late March 2014. In 2013, LabStyle received CE Mark approval for the marketing and approval of the Dario™ system.
The AMAR approval is the latest milestone in LabStyle’s global regulatory strategy. In early 2014, LabStyle announced that it filed a 510(k) application with the U.S. Food and Drug Administration (FDA) to allow for the marketing of Dario™ in the U.S.
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.
"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" said Erez Raphael, LabStyle’s President and CEO. "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. With Dario™, diabetes management is not only about generating accurate blood glucose measurements but also gathering and providing practical information, analysis and suggestions, including through via social community channels, to help those with diabetes make better informed decisions and improve their lifestyle."
Dario™ is a cloud-based, diabetes management solution which includes novel software applications combined with the stylish, ‘all-in-one’, pocket-sized, Dario™ Smart Meter which interfaces with a user’s mobile device to form the overall Dario™ Diabetes Management Solution, allowing diabetics to monitor their blood sugars and other activities and gain insights into managing their disease using their mobile devices.
The Dario™ App has already been launched in Israel and is available on the App store for iPhones and on Google Play for Android smartphones.
According to the International Diabetes Federation, diabetes affects more than 8% of the adults in Israel from the age of 20-79 and its prevalence is growing.
