DarioHealth Receives U.S. FDA Clearance for Certain Leading Android Devices in the U.S.
Significantly expands U.S. market opportunity
Jul 20, 2017
CAESAREA, Israel, July 20, 2017 DarioHealth Corp. (NASDAQ: DRIO), a leading global digital health company with mobile health and big data solutions, today announced that the United States Food and Drug Administration (FDA) has granted Pre-market Notification (510(k)) clearance for the Dario app on certain leading Android smart mobile devices (SMD).
This news opens a significant U.S. market opportunity for DarioHealth, as it enables DarioHealth to launch its flagship app also in U.S. Google play store and expand the sales of the Dario Blood Glucose Monitoring System to certain leading SMD. The leading SMD cleared include Samsung Galaxy S series, Samsung Galaxy Note series and LG G series.
Erez Raphael, Chairman and CEO of DarioHealth, commented, "We are very excited to receive the FDA's marketing clearance for the Dario product on leading Android devices. This continues DarioHealth's U.S. market progress, and truly opens the door for wide-scale expansion in this pivotal market. Of course, this milestone is a testament to our superb teamwork, and I am proud of the hard work and success that our talented team has achieved."
DarioHealth has been marketing the product in the U.S. exclusively for Apple iOS 6.1 platform and higher since the FDA first granted clearance for the Dario Blood Glucose Monitoring System in December 2015. With today's news, DarioHealth plans to expand U.S. sales in the coming weeks.
About DarioHealth Corp.
DarioHealth Corp. is a leading global digital health company serving tens of thousands of users with dynamic mobile health solutions. We believe people deserve the best tools to manage their treatment, and harnessing big data, we have developed a unique way for our users to analyze and personalize their diabetes management. With our smart diabetes solution, users have direct access to track and monitor all facets of diabetes, without having the disease slow them down. The acclaimed Dario™ Blood Glucose Monitoring System all-in-one blood glucose meter and native smartphone app gives users an unrivaled method for self-diabetes management. DarioHealth is headquartered in Caesarea, Israel with a regional office in Burlington, Massachusetts. For more information, visit http://mydario.investorroom.com/.
Cautionary Note Regarding Forward-Looking Statements
This news release and the statements of representatives and partners of DarioHealth Corp. (the "Company") related thereto contain 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, when the Company states that FDA clearance for certain leading Android devices opens a significant market opportunity, and when it states that it expects to expand U.S. sales in the coming weeks it is using 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 the Company's commercial and regulatory plans for Dario(TM)) 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 DarioHealth Corp.