The Israel-based company’s product is designed to work with Apple’s latest smartphones, which feature a Lightning connector in place of a standard headphone jack.
DarioHealth’s platform includes a blood glucose monitor that connects to a mobile device, as well as a lancing device and test strips. Users can access real-time and historical blood glucose data to watch out for trends, according to DarioHealth.
The company first won FDA clearance for an Apple-compatible version of its blood glucose monitoring system in December 2015 and later won approval for systems designed for Android devices.
“We’ve been working tirelessly to bring forth a solution that would meet the rigorous standards required to achieve the FDA clearance,” chairman & CEO Erez Raphael said in prepared remarks.
“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,” he added.