7. Device Update

Insulet’s Omnipod® DASH™ Insulin Management System Receives FDA Clearance

Insulet Corporation has received FDA clearance for the Omnipod® DASH™ Insulin Management System.

Omnipod DASH™ Insulin Management System is a tubeless, wearable insulin pump that holds up to 200 units of insulin. It allows continuous insulin delivery through customizable basal rates and bolus amounts. The system features Bluetooth® wireless technology for connectivity between the color touch-screen Personal diabetes manager (PDM), tubeless waterproof pump (Pod), and is optimized for use with the CONTOUR® NEXT ONE blood glucose meter for the seamless transfer of blood glucose readings to the PDM’s bolus calculator. With a suite of mobile apps viz. Omnipod DISPLAY™ and Omnipod VIEW™, the system also provides the capability to see Omnipod DASH™ System data on a user's or his caregiver’s iOS smartphone.

Insulet is planning to conduct a six-month, limited market release of the Omnipod DASH ™ system in the United States and the commercial release is anticipated for early 2019.

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