The Food and Drug Administration granted the Israeli digital health company DarioHealth Corp. pre-market notification 510(k) clearance for its app on certain Android smartphones.
DarioHealth's Dario Blood Glucose Monitoring System has been available on the Apple iOS 6.1 platform and higher in the U.S. since earning FDA clearance in 2015. The Dario Blood Glucose Monitoring System comprises a blood glucose meter and associated app that supports users in diabetes self-management.
This most recent FDA clearance enables DarioHealth to launch the Dario Blood Glucose Monitoring System in the U.S. Google Play store for smartphones in the Samsung Galaxy S series, Samsung Galaxy Note series and LG G series.