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Insulet Submits Second-Generation OmniPod for FDA Review

Published: 6/1/11

Insulet, which makes the OmniPod disposable insulin pump, has submitted a next-generation OmniPod for FDA review. The new pod is approximately 40% smaller than the current version and roughly 25% lighter. The pump system’s handheld device (which Insulet calls a Personal Diabetes Manager or PDM) will be new as well, with a built-in blood glucose meter that uses Abbott’s new FreeStyle strips. The FDA review process for insulin pumps lasts a minimum of 90 days, which means the soonest the FDA would clear the next-generation pod is early August. However, the current FDA requirements for insulin pumps are quite complex (Insulet had to submit a 7,800 page document – in triplicate), and the company has stated that it hopes to have the approval from the FDA by the end of the year. Insulet is still considering how to launch the second-generation device once it is cleared by the FDA. However, the company has discussed one plan that would involve a 6-12 month transition. Under this plan, every current OmniPod user would receive for free the new PDM; the customers who have been using OmniPod the longest would be the first to get the new system). Insulet has not discussed the price of the PDM for people who are new to the OmniPod, but we assume it will be comparable to the price of the original PDM. The new pods will have the same average price as the old pods.

The device has been under regulatory review in the European Union since February, and Insulet hopes to receive EU approval by late June. Meanwhile, Insulet continues to work with Dexcom on a new product that will integrate the second-generation OmniPod with Dexcom’s fourth-generation continuous glucose monitoring system (which Dexcom intends to submit to the FDA as a stand-alone product in late summer). The companies plan to submit their combined pump/CGM to the FDA in the first half of 2012, as we wrote in our update on Dexcom’s fourth-generation system in New Now Next in diaTribe #31. --JPS

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