NEW YORK and CAESAREA, Israel, March 26, 2018 /PRNewswire/ -- DarioHealth Corp. (NASDAQ: DRIO), a leading global digital health company with mobile health and big data solutions, announced today that the United States Food and Drug Administration (FDA) has granted Pre-market Notification (510(k)) clearance for the Company's Lightning®-enabled version of the acclaimed Dario™ Blood Glucose Monitoring System which enables the use of the Dario app on iPhone 7, 8 and X smart mobile devices (SMD). Consumers in the U.S. market will be able to receive the same quality user experience with DarioHealth on the latest Apple devices, including the iPhone X.
The launch of Apple's smartphones with only a Lightning connector posed a unique challenge to the entire mobile ecosystem. With today's announcement, DarioHealth can now successfully offer to U.S. consumers its proprietary meter with either a 3.5mm headphone jack or Lightning connector.
This news opens a significant U.S. market opportunity for DarioHealth, as it enables DarioHealth to provide its diabetes management platform and expand the sales of the Dario Blood Glucose Monitoring System to iPhone 7, 8 and X SMDs.
Erez Raphael, Chairman and CEO of DarioHealth, commented: "We've been working tirelessly to bring forth a solution that would meet the rigorous standards required to achieve the FDA clearance. We are proud that our organization worked with agility to ensure connectivity to the latest Apple devices. This is a big breakthrough to receive the FDA's marketing clearance for the Dario product on iPhone 7, 8 and X, and allows many of our past users who upgraded to these new iPhones to renew their Dario experience. 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, and certain leading Android SMD's including Samsung Galaxy S series, Samsung Galaxy Note series, and LG G series, since September 2017. With today's news, DarioHealth plans to expand U.S. sales in the coming weeks.
About DarioHealth Corp.
DarioHealth Corp. (NASDAQ: DRIO) is a leading global digital health company serving its users with dynamic mobile health solutions. In today's day and age, knowledge of health and treatment is being democratized, and we believe people deserve to know everything about their own health and have the best tools to manage their condition. DarioHealth employs a revolutionary approach whereby harnessing big data, we have developed a novel method for chronic disease data management, empowering people to analyze and personalize self-diabetes management in a totally new way without having the disease slow them down. DarioHealth has a commercial office in New York with an R&D center in Caesarea, Israel. 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 iPhone 7, 8 and X 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™) 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.
DarioHealth Corporate Contact: Shmuel Herschberg, Marketing Director, [email protected], +1-914-775-5548
DarioHealth Public Relations Contact: Terese Kelly, Rosica PR, [email protected], +1-201-843-5600
DarioHealth Investor Relations Contact: Westwicke Partners, [email protected], +1-443-213-0500
SOURCE DarioHealth Corp.