FDA Audit Slows Down Medtronic Launch Plans For Low-Glucose-Suspend Diabetes System
This article was originally published in The Gray Sheet
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.
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Medtronic recently announced FDA approval of its MiniMed 530G low-glucose-suspend insulin pump, the first system approved in the U.S. that can automatically stop insulin delivery when blood glucose levels fall to a pre-set level.
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The company’s leadership team is “determined to transform Medtronic from being a primarily device provider today into the premier global medical technology solutions partner of tomorrow,” CEO Omar Ishrak said.