NEW YORK and CAESAREA, Israel (March 26, 2018)—Digital health company DarioHealth Corp. received FDA pre-market notification (510(k)) clearance for the company’s Lightning-enabled (3.5mm headphone jack) version of the Dario Blood Glucose Monitoring System. This news opens a significant U.S. market opportunity and enables the use of the Dario app on iPhone 7, 8 and X smart mobile devices (SMD).
Dario Blood Glucose Monitoring System
LAS VEGAS (March 15, 2016)—LabStyle Innovations Corp. developer of the Dario Blood Glucose Monitoring System, announced today the national availability of Dario in the U.S. The U.S. rollout follows the U.S. Food and Drug Administration's 510(k) clearance of the Dario in December 2015. The Dario made its U.S.
NEW YORK (February 25, 2016)—The U.S. FDA recently opened the doors to new mobile health technology to the millions of Americans managing their diabetes by granting an important 510K clearance for the Dario Blood Glucose Monitoring System for use in the U.S.