Home News LabStyle Innovations files 510(k) in the US

LabStyle Innovations files 510(k) in the US

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Filing of 510(k) is for FDA clearance of the Dario blood glucose monitoring system, a cloud-based, mobile health platform for diabetes.

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Manufacturing Group January 9, 2014

Executives from LabStyle Innovations Corp., developer of Dario, a cloud-based, mobile medical device health platform for diabetes and blood glucose monitoring, announced that it has filed a Premarket Notification Application, also known as a 510(k), with the US Food and Drug Administration (FDA) for the Dario blood glucose monitoring system.

"We are right on schedule, according to our previously announced plans. We have filed the 510(k) with the FDA in the United States for the Dario blood glucose monitoring system, one of three key components of the complete platform. The system includes: the dongle, the lancing device, the software application that shows the glucose level from the Dario dongle, the test strips, the check strip, the control solutions and lancets. Meanwhile, we are continuing our world rollout of Dario throughout Europe and the South Pacific. We are looking forward to achieving other milestones for LabStyle in 2014," said LabStyle president and chief executive officer Erez Raphael.

The complete Dario diabetes management platform combines the aforementioned all-in-one, blood glucose monitoring system, a smart phone application (iOS & Android), and a website application.

Dario is the first complete diabetes management platform designed to empower people with diabetes to take charge of their health with the right tools, insights, and support, right in their pocket. With access to both real-time and historical blood glucose data, the Dario platform is designed to spot patterns, recommend the right treatments, and support behavior change efforts. In the future, Dario will help doctors to better identify patients at high-risk, to make, more frequently, better and faster clinical decisions, and to more easily, routinely follow-up. The Dario platform is also expanding to assist health systems in automatically targeting resources to patients who are most likely to have acute or long-term complications.

Raphael continued, "I'd like to take this opportunity to thank our investors, partners, associates and the thousands living with diabetes worldwide who have heard our story for their continued enthusiasm and support. We achieved great things at LabStyle in 2013, and we are continually working to put in place the pieces for future achievements and growth at the company. We would like to wish the entire Dario community and their families, a very happy, healthy and prosperous 2014."

Dr. Oren Fuerst, chairman of the board of LabStyle, said, "This is a wonderful way to end 2013 and ring in 2014. Submitting the 510(k) is truly a remarkable milestone in the company's evolution, especially considering its short history. The submission is the culmination of a great deal of impressive team work and dedication by the company's employees, management, and officers."

LabStyle's world roll-out of the Dario diabetes management platform began on Dec.12, 2013, with the market launch of the Dario iOS app in the United Kingdom, Australia and New Zealand. The Dario iOS app is now available in these countries for free download at the Apple app store. LabStyle remains on course to launch the Dario iOS app in Italy and Belgium and the Dario Android app, in the United Kingdom, New Zealand, Australia, Italy and Belgium – both during first quarter 2014. Plans are also on track to soft launch the Dario all-in-one blood glucose monitoring device in the United Kingdom and in Italy during first quarter 2014.

Source: LabStyle Innovations Corp.

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