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Medtronic Gets Extra FDA Attention To Hasten Approval Of Next-Gen Insulin Pump

CDRH has formed a close working partnership with Medtronic to facilitate quick approval for a next-generation insulation pump-glucose monitor, offering an illustration of what the center’s future plans might be for addressing devices with breakthrough potential.

FDA in recent months has been going the extra mile to aid Medtronic PLCin its regulatory development of a next-generation insulin pump-glucose monitor system, according to a company official

That has meant monthly, in-person meetings where agency officials provide detailed feedback on the company’s clinical plan, explains Patricia Shrader, Medtronic’s VP, Corporate Regulatory and External Affairs. Such regular meetings...

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