Insulin management system receives FDA 510(k) clearance

19th June 2018

Insulet

Enaie Azambuja

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Insulet has announced FDA 510(k) clearance of the Omnipod DASH Insulin Management System (Omnipod DASH). “Omnipod DASH was inspired by Podders and embodies what users on multiple daily injections have been asking for in a diabetes management system,” said Patrick Sullivan, Chairman and Chief Executive Officer. “Our number one priority is to continue to minimise the daily strain on those impacted by diabetes and we are confident this system, and eliminating the system’s upfront cost, do just that."

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 optimised for use with the CONTOUR NEXT 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 Today 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.

“I’m thrilled with the new Omnipod DASH System,” said Tessa Mellinger, a college student with Type 1 diabetes who was part of the DASH user testing and development.

“The PDM display is easy to read, the steps to managing basal rates are user friendly, and the food library is really helpful. The fact that it looks like a smartphone makes it cool to carry and may help eliminate those awkward questions from strangers.”

Insulet would like to thank the Centers for Devices and Radiological Health (CDRH) branch of the FDA for its collaborative efforts, timely review and ultimate clearance of the Omnipod DASH Insulin Management System submission. Insulet looks forward to working with Captain Alan Stevens and his team as the Company continues to work on its robust innovation pipeline.

Submission for FDA 510(k) clearance of the Omnipod DASH was announced in January, and while today’s clearance allows Insulet to commercialise 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.