NEW YORK and CAESAREA, Israel (March 26, 2018)—Digital health company DarioHealth Corp. received FDA pre-market notification (510(k)) clearance for the company’s Lightning-enabled (3.5mm headphone jack) version of the Dario Blood Glucose Monitoring System. This news opens a significant U.S. market opportunity and enables the use of the Dario app on iPhone 7, 8 and X smart mobile devices (SMD).
“We’ve been working tirelessly to bring forth a solution that would meet the rigorous standards required to achieve the FDA clearance," said Erez Raphael, chairman and CEO of DarioHealth. "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."
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 SMDs, including Samsung Galaxy S series, Samsung Galaxy Note series, and LG G series, since September 2017.
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