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New diabetes device approved.(Regulatory and Safety Action)

WHO Drug Information

| June 22, 2003 | COPYRIGHT 1999 World Health Organization. (Hide copyright information)Copyright

United States of America -- The Food and Drug Administration (FDA) has cleared the first device for diabetics which integrates a glucose meter and insulin pump with a dose calculator. The new device could be the first step in the development of a fully automated glucose monitoring and insulin delivery system.

The product, made by Medtronic MiniMed, Inc., and Becton Dickinson, combines the Medtronic MiniMed Paradigm insulin pump[R] with a Becton Dickinson glucose monitor and facilitates data interchange between the two. It has additional circuitry and software modifications that allow it to transmit glucose values to the insulin pump and to transfer data between the …

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