Insulet Corp. said the U.S. Food and Drug Administration granted 510(k) clearance to its Omnipod Dash insulin management system.
The system includes a handheld personal diabetes manager that is designed for use with a blood glucose meter and certain mobile applications.
The approval allows Insulet to commercialize the product in the U.S., with full market release expected to start early 2019.
Billerica, Mass.-based Insulet is a medical device company that develops and sells insulin delivery systems for people with insulin-dependent diabetes.
