Global digital health outfit DarioHealth Corp., which emphasises mobile health and data solutions, has been granted Pre-market Notification (510(k)) clearance for the Dario app on certain Android mobile devices by the U.S. Food and Drug Administration.
Dario is a glucose meter that syncs with a companion app. The device, which is small enough to fit in someone’s pocket, consists of a glucose meter, a disposable test strip cartridge, and lancing device. The companion app, available on iOS and Android devices, includes a nutrition guide, logbook, and monitoring system. The app allows users to view all their information as well as insights and patterns in their data.
The clearance has the potential to increase the company’s market share. It can now launch its flagship app in the U.S. through the Google Play store and and expand the sales of the Dario Blood Glucose Monitoring System to certain leading SMD, including Samsung Galaxy S series, Samsung Galaxy Note series and LG G series.
Erez Raphael, Chairman and CEO of DarioHealth, said the development continues the progress made in the U.S. market 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."
To date, DarioHealth had been marketing the product in the U.S. exclusively for the Apple iOS 6.1 platform and higher; the FDA first granted clearance for the Dario Blood Glucose Monitoring System in December 2015.