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news.Insulet, a medical device company, has received the CE Mark approval for its OmniPod insulin management system. The CE Mark gives Insulet authorization to distribute the OmniPod system throughout the EU and in other countries that recognize the CE Mark.
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According to Insulet, the OmniPod insulin management system is the first and only continuous insulin delivery system of its kind in the market. The OmniPod system offers people living with insulin-dependent diabetes all the benefits of insulin pump therapy, with unprecedented freedom, comfort and ease in managing their diabetes.
Unlike conventional insulin pumps, the OmniPod system has no tubing and features automated, virtually pain-free insertion. It has just two, wireless components: the Pod – a compact, lightweight, self-adhesive insulin delivery device that is worn discreetly on the skin beneath clothing; and the Personal Diabetes Manager – a wireless, menu-driven, hand-held device that programs the Pod, the company said.
Insulet is in discussions regarding international distribution options for the OmniPod system. The company anticipates that the product will be available to a limited extent in selected markets in 2009 with broader availability in 2010.
Carsten Boess, vice president of international at Insulet, said: “The easy-to-use, tubing-free OmniPod System eliminates the obstacles that often prevent people with diabetes from choosing the best treatment option, insulin pump therapy. We are eager to be able to offer our innovative product in Europe, where we have already received tremendously positive feedback from key opinion leaders.”