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FDA Audit Slows Down Medtronic Launch Plans For Low-Glucose-Suspend Diabetes System

A recent FDA inspection of Medtronic’s diabetes business identified quality systems deficiencies that are likely to delay the firm’s launch of its first-of-a-kind MiniMed 530G insulin pump/continuous glucose monitoring system.

Medtronic’s planned launch of its MiniMed 530G low-glucose-suspend insulin pump/continuous glucose monitor system will be delayed as the company addresses questions from FDA triggered by a recent inspection.

The firm says it is now looking toward a launch of the novel diabetes system by the end of 2013,...

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