LabStyle Innovations Receives U.S. FDA Marketing Clearance for the Dario Blood Glucose Monitoring System
Smartphone-based blood glucose monitor with unique all-in-one design cleared for launch in the world's largest diabetes market
Dec 22, 2015
CAESAREA, Israel, Dec. 22, 2015 /PRNewswire/ -- LabStyle Innovations Corp. (OTCQB: DRIO), developer of the Dario™ Diabetes Management Solution, today announced that the United States Food and Drug Administration (FDA) has granted 510(k) clearance for the Dario Blood Glucose Monitoring System, including its components, the Dario Blood Glucose Meter, Dario Blood Glucose Test Strips, Dario Glucose Control Solutions and the Dario app on the Apple iOS 6.1 platform and higher.
"We are very pleased and excited to receive the FDA's marketing clearance for Dario. While Dario has already been approved in numerous countries throughout the world, the U.S. is the single largest market in the global blood glucose monitoring market." stated LabStyle Chairman and CEO Erez Raphael. "We believe sales in the U.S. will have a substantial impact on LabStyle's financial performance and value."
"Based on our experience in the markets where we've already launched, we believe Dario offers a superior user engagement when compared to alternative devices. We believe people in the U.S. will have a similarly favorable user experience. This is the core competitive advantage of Dario," added Todd Durniak, LabStyle's Executive Vice President and General Manager for the U.S. "Having received marketing clearance, we are now preparing for the imminent launch of Dario in the U.S."
"In the future we look forward to expanding the indications and platforms on which Dario will be used in the U.S.," Durniak added.
The Dario Blood Glucose Monitoring System is indicated for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The compact all-in-one system helps people with diabetes monitor their blood sugar levels and proactively manages their diabetes using their smartphone. Dario connects via a headphone jack to turn a mobile device into a glucose monitor, and incorporates a lancing device and test strips together with the meter in an all-in-one easy to carry device to take blood glucose measurements on the spot. Unlike conventional glucose monitors, there is no carrying case or batteries to replace. Dario provides real-time and historical blood glucose data to allow health care providers to spot patterns, recommend treatments and support behavior changes. Dario's web interface also makes it easy for users to share health information with healthcare providers and loved ones.
About LabStyle Innovations
LabStyle Innovations Corp. (OTCQB: DRIO) develops and commercializes patent-pending technology providing consumers with laboratory-testing capabilities using smart mobile devices. LabStyle's flagship product is the Dario™ Blood Glucose Monitoring System. Dario™ received U.S. FDA clearance in December 2015 and received Europe's CE mark certification in September 2013. World rollout began 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, the content of which is not part of this press release: www.mydario.com and http://mydario.investorroom.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. For example, we are using forward-looking statements when we discuss our belief that sales in the U.S. will have a substantial impact on our financial performance and value, whether users of Dario in the U.S. will have a favorable experience, preparations for the imminent launch of Dario in the U.S. and expanding indications and platforms for Dario. 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 the Company's commercial and regulatory plans for Dario™ as described herein) 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.
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SOURCE LabStyle Innovations Corp.