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Insulet Receives 510(k) Clearance For OmniPod Insulin Management System

Insulet Corp.(PODD) announced Friday that it has received 510(k) clearance from the U.S. Food and Drug Administration or FDA for the next-generation OmniPod Insulin Management System.

The new OmniPod insulin pump is more than one-third smaller and one-quarter lighter than the original model, while maintaining the same 200-unit insulin reservoir capacity and easy-to-use features.

In addition to the smaller, lighter Pod, the new OmniPod System includes an updated Personal Diabetes Manager or PDM that also features a series of enhancements.

"Preparations are underway to launch the new OmniPod, including training of healthcare professionals and transitioning the rest of our manufacturing production. We expect that these initiatives will take approximately two to three months to complete and anticipate our first shipments in the U.S. to occur in late Q1 2013. Like the System itself, converting our current OmniPod users to the new system has been designed to be extremely easy as to ensure a seamless transition," said Duane DeSisto, President and Chief Executive Officer of Insulet.

by RTT Staff Writer

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