The approval expands the Israel-based company’s availability from exclusively Apple (NSDQ:AAPL) iOS products, which it has had clearance on since winning FDA clearance for its Dario blood glucose monitoring system in December 2015.
DarioHealth said the approval will allow the company to expand its availability to leading smartphone devices, and that it has plans to expand its US sales over the next few weeks.
“We are very excited to receive the FDA’s marketing clearance for the Dario product on leading Android devices. 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,” chair & CEO Erez Raphael said in a prepared statement.
Last July, LabStyle Innovations rebranded under the corporate moniker DarioHealth. The Boston-based company said the new name reflected the “company’s growth and development in the digital health and mHealth space.”