DarioHealth (NSDQ:DRIO) said today that it won CE Mark approval for the version of its Dario blood glucose monitoring system that fits with the Lightning connector on Apple’s iPhone 7 and iPhone 8 smart phones.
With this regulatory win, DarioHealth’s smart glucose meter can be used with a 3.5 mm headphone jack or Lightning connector, the company said. Shares in the company jumped more than 13% today, trading at $2.05 apiece in early morning activity.
“We’ve been working tirelessly to bring forth a solution that would meet the rigorous standards required to achieve the CE Mark,” 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 significant milestone will allow us to open to a whole new market segment and reengage with former-Dario users who now have the newest Apple devices.
“The actual Lighting-enabled prototype has been ready for a long time, and the CE Mark is just the beginning. We will continue to support our users around the world and, to that end, have begun the formal process with regulatory agencies in the U.S., Canada, and Australia.”
DarioHealth’s platform includes a blood glucose monitoring system, which connects via a headphone jack to a mobile device, a lancing device and test strips, which help diabetes patients monitor their blood glucose throughout the day. There is no carrying case or batteries, according to DarioHealth, and users can access real-time and historical blood glucose data to watch out for trends.
Earlier this month, DarioHealth launched its smart diabetes platform in Germany – the ninth country in which the Israel-based company’s technology is commercially available.