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FDA approves Insulet’s Omnipod DASH insulin management system

MDBR Staff Writer Published 05 June 2018

Insulet has bagged 510(k) clearance from the US Food and Drug Administration (FDA) for its Bluetooth wireless technology-based Omnipod DASH insulin management system.

The Omnipod DASH system features Bluetooth wireless technology for connectivity between the color touch-screen Personal Diabetes Manager (PDM) and tubeless waterproof pump (Pod).

It is optimized for use with the Contour Next One Blood Glucose (BG) Meter for transferring blood glucose readings the seamlessly to the bolus calculator of the PDM, said Insulet.

The Bluetooth functionality also helps in giving connectivity to the Omnipod Display and Omnipod View apps. The DASH PDM will be provided free of cost by with the purchase of Pods, said Insulet.

Insulet chairman and CEO Patrick Sullivan said: “Omnipod DASH was inspired by Podders and embodies what users on multiple daily injections have been asking for in a diabetes management system.

“Our number one priority is to continue to minimize the daily strain on those impacted by diabetes and we are confident this system, and eliminating the system’s upfront cost, do just that.”

The Omnipod Display and Omnipod View apps, in turn, will enable users and their caregivers fast and convenient access to their insulin therapy details on their smartphones.

Through Omnipod Display, users can monitor their PDM data discreetly on their smartphones. Omnipod View, on the other hand, gives parents and caregivers the scope to monitor the diabetes levels of their loved ones more easily.

Users and their care teams through the iOS Today View widget can check their or their loved ones’ PDM and continuous glucose monitor (CGM) data on one smartphone screen with a single swipe.

The FDA clearance will enable commercialization of the product in the US. However, Insulet said that it will adopt a measured approach through a limited launch in the market to make sure of an ideal user experience during the time of full market release, which is likely to commence in early 2019.