LabStyle Innovations Launches Dario Blood Glucose Monitor in the United States

LabStyle Innovations Corp., developer of the Dario Blood Glucose Monitoring System, has officially launched the system in the United States. The U.S. rollout follows the U.S. Food and Drug Administration’s (FDA) 510(k) clearance of the Dario in December 2015.

The Dario made its U.S. debut at Medtrade’s home medical equipment/durable medical equipment trade show earlier this month in Las Vegas, Nev.

The Dario App is now also available through the App Store and ready for download by users across the U.S. Sales through various non-exclusive third party distributors and medical equipment suppliers are anticipated over the first half of 2016.

“The U.S. is the world’s largest market for glucose monitoring and the launch of national availability represents a transformative achievement not only for Dario, but more importantly for users,” said Erez Raphael, chairman and CEO of LabStyle Innovations.

“Our unique ability to deliver a user-centric approach to monitoring glucose levels and other important behavioral factors will help usher in a new era for diabetes management in the U.S., delivering significant value to users, healthcare providers and the entire American healthcare system,” added Todd Durniak, LabStyle’s executive vice president and general manager for North America.

The Dario Blood Glucose Monitoring System consists of an all-in-one Smart Meter that plugs directly into smartphones coupled with a robust, real-time mobile app, that allows users to track and monitor data such as: blood glucose measurements, carbs and insulin intake, as well as physical activity directly on their mobile devices, making diabetes data management much simpler. Additionally, users can share this data with their community, family and medical staff.

The Dario app integrates with popular apps such as RunKeeper, helping diabetics better manage exercise and fitness activities, and FatSecret, which allows for better food intake management. Instantly generated, personalized reports help users better understand why their blood glucose levels may change.

Dario is a pocket-sized all-in-one diabetes management solution that provides users globally with important disease management features such as emergency hypoglycemia contacts, actionable insights and easy information sharing with medical staff. The Dario Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood. The Dario is intended for self-testing outside the body (in-vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control.

The Dario Blood Glucose Monitoring System consists of a device housing that includes a blood glucose meter and lancing device. The system also includes test strips, lancets, control solutions and a mobile application. The Dario meter does not require coding or separate batteries. The Dario meter is powered via the 3.5mm audio headphone jack of the smart mobile device. Users are instructed to insert the test strip into the meter, apply the blood or control solution to the test strip, after which the meter will process the test in approximately six (6) seconds and display the test result on the smart mobile device screen via the mobile application.

The Dario Blood Glucose Monitoring System uses Apple’s iOS smart mobile device technology to view the glucose test results via a mobile application. This application is available for download via the smart mobile device’s application store.

LabStyle Innovations Corp. creates mobile and digital tools that empower and engage users to lead healthier lives. LabStyle’s flagship product is the Dario Blood Glucose Monitoring System, which received FDA clearance in December 2015 and received Europe’s CE mark certification in September 2013.