FDA grants 510 (k) approval for Omnipod DASH Insulin Management System (Omnipod DASH) tubeless insulin pump technology.- Insulet Corporation.

Insulet Corporation the leader in tubeless insulin pump technology with its Omnipod Insulin Management System (Omnipod System), announced FDA 510(k) clearance of the Omnipod DASH Insulin Management System (Omnipod DASH).

Omnipod DASH was built to be simple, discreet and easy-to-use. 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 EXT ONE Blood Glucose (BG) Meter for the seamless transfer of blood glucose readings to the PDM�s bolus calculator. Bluetooth functionality also provides connectivity to the Omnipod DISPLAY and Omnipod VIEW apps. The DASH PDM will be offered at no cost with the purchase of Pods.

The Omnipod DISPLAY and Omnipod VIEW apps will provide users and their caregivers quick and easy access to their insulin therapy information on their smartphones. Omnipod DISPLAY allows users to discreetly monitor their PDM data on their smartphones along with other Podder-inspired features including �Find my PDM�. Omnipod VIEW allows parents and caregivers to monitor their loved ones� diabetes more easily and with greater peace of mind. The iOS View widget allows users and their care teams to see their or their loved ones� PDM and continuous glucose monitor (CGM) data on one smartphone screen with one swipe.

While this clearance allows Insulet to commercialize this product in the United States, the Company is taking a measured approach through a limited market launch to ensure an ideal user experience at full market release. Full market release is estimated to begin in early 2019 in the United States.