FDA grants 510(k) approval to Omnipod DASH Insulin Management System.- 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).

Submission for FDA 510(k) clearance of the Omnipod DASH was announced in January, and while 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.

The system relies on a tubeless stick-on insulin pump that can stay hidden and discreet under the skin.The system comes with a smartphone-like device that interfaces with the pump and keeps track of readings and amount of insulin delivered over time. If used along with the CONTOUR NEXT ONE blood glucose reader, the system can keep track of sugar levels and help to adjust the delivery of insulin accordingly.

Comment: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 the users� diabetes more easily and with greater peace of mind. The iOS Today View widget allows users and their care teams to see their or their users PDM and continuous glucose monitor data on one smartphone screen with one swipe..

The Omnipod DASH system is not yet available in Canada or Europe.