Israeli company DarioHealth has received a 510(k) approval for a version of its blood glucose monitoring system that is compatible with the iPhone 7, 8 and X along with the Dario app, according to a company statement.
        “We have worked tirelessly to find a solution that meets the rigorous standards required to obtain FDA approval,” said Erez Rafael, CEO and Chairman of DarioHealth. allowing many of our past users who have migrated to these new iPhones to upgrade their Dario capabilities. This continues DarioHealth’s progress in the US market and really opens the door to massive market expansion.
       The Dario system consists of a pocket device that includes a glucometer, disposable test strips, lancing device, and an accompanying smartphone app.
        DarioHealth originally received FDA clearance for a digital diabetes monitoring system in December 2015, but was sidelined when Apple announced its controversial decision to remove the headphone jack due to hardware reliance on the 3.5mm headphone jack. device manufacturers only support Apple’s proprietary Lightning connector.
        “This news [removal of the 3.5 mm jack] did not come as a surprise to us, we have been working on a solution for a long time,” Rafael said in 2016. healthcare market. “
       The Lightning-compatible DarioHealth system received CE marking in October and has been available since September on select Android smartphones in the US, such as the Samsung Galaxy S series, Samsung Galaxy Note series, and LG G series. Following a recent customs clearance, the company said it intends to expand its sales to USA in the coming weeks.
        During a teleconference last November, Raphael discussed several key topics, including Lightning compatibility and expanding US sales. His other comments included his thoughts on DarioHealth’s launch of the company’s new B2B platform, Dario Engage, in the German market.