LabStyle Innovations Files 510(K) In The U.S. For FDA Clearance Of The Dario Blood Glucose Monitoring System
1/7/2014 11:06:10 AM
CAESAREA, Israel, Jan. 7, 2014 /PRNewswire/ -- LabStyle Innovations Corp. (OTCQB:DRIO), developer of Dario, a cloud-based, mobile health platform for diabetes and blood glucose monitoring, announced today 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.
Mr. 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 December 12th 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 DarioiOS app in Italy and Belgiumand the DarioAndroid 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.
About LabStyle Innovations
LabStyle Innovations Corp. (OTCQB:DRIO) is a mobile health (mHealth) company developing and commercializing patent-pending technology providing consumers with laboratory-testing capabilities using smart phones. LabStyle's flagship product, Dario, is a mobile, cloud-based, diabetes management platform which includes an 'all-in-one', pocket-sized, blood glucose monitoring system, iOS and Android apps and a web application. Dario received CE mark certification in September 2013 and began its world rollout in select countries in December 2013. LabStyle is pursuing patent applications in multiple areas covering the specific processes related to blood glucose level measurement as well as more general methods of rapid tests of body fluids using mobile devices and cloud-based services. For more information: www.mydario.com.
Cautionary Note Regarding Forward-Looking Statements
This news release and the statements of representatives and partners of LabStyle Innovations Corp. (the "Company") related thereto contains or may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "plan," "project," "potential," "seek," "may," "will," "expect," "believe," "anticipate," "intend," "could," "estimate" or "continue" are intended to identify forward-looking statements. Readers are cautioned that certain important factors may affect the Company's actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect the Company's results include, but are not limited to, regulatory approvals, product demand, market acceptance, impact of competitive products and prices, product development, commercialization or technological difficulties, the success or failure of negotiations and trade, legal, social and economic risks, and the risks associated with the adequacy of existing cash resources. Additional factors that could cause or contribute to differences between the Company's actual results and forward-looking statements include, but are not limited to, those risks discussed in the Company's filings with the U.S. Securities and Exchange Commission. Readers are cautioned that actual results (including, without limitation, the timing for and results of FDA review of Dario, the Company's anticipations of the functionality of Dario, and the results of the Company's commercialization efforts for Dario) may differ significantly from those set forth in the forward-looking statements. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
Dario and the Dario logo are trademarks owned by LabStyle Innovation Ltd.
© 2013 LabStyle Innovations Corp. All rights reserved.
SOURCE LabStyle Innovations Corp.
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