Israel-based LabStyle Innovations, maker of a smartphone-connected glucometer called Dario, has launched the device in the US, Dario secured its FDA 510(k) clearance in December.
"The US is the world's largest market for glucose monitoring and the launch of national availability represents a transformative achievement not only for Dario, but more importantly for users," LabStyle Innovations CEO Erez Raphael said in a statement.
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.
Through a partnership with FatSecret, which was announced in April 2014, users are also able to quickly log food from FatSecret's database to track their calorie and carb intake.
Earlier this month, LabStyle announced that it was listing the company on the NASDAQ Capital Market, formerly the Nasdaq SmallCap Market. The company had raised at least $12.5 million before they listed, and raised about $8.5 million initially as part of the listing.
Last summer, LabStyle launched Dario in Canada. The system sells through pharmacies and online and can be reimbursed through a majority of medical plans, LabStyle said.
The company has had a CE Mark for the system since September 2013.