Digital health company DarioHealth has been granted pre-market notification clearance for the Lightning-enabled version of its Blood Glucose Monitoring system, enabling the use of the Dario app on the latest iPhones.
The 510(k) clearance was needed due to Apple’s latest smartphones only having a lightning connector. The product enables DarioHealth’s monitoring system to connect with either a 3.5mm headphone jack or lightning connector.
DarioHealth’s Blood Glucose monitoring system is now able to work with the latest Apple device, including the iPhone X.
Erez Raphael, chairman and CEO of DarioHealth, said: “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 organisation 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.”