Medtronic (MDT) said Thursday that it has submitted 510(k) applications to the US Food and Drug Administration (FDA) seeking marketing approval for its MiniMed 780G interoperable pump as an alternate controller enabled insulin pump and SmartGuard algorithm as an interoperable automated glycemic controller.
Medtronic said the submissions are part of a deal announced in August with Abbott Laboratories (ABT) to collaborate on an integrated system based on Abbott's continuous glucose monitoring platform.
Under the agreement, Abbott is supplying Medtronic with a CGM that will work exclusively with Medtronic's smart dosing devices and software.
According to the FDA, a 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective as a legally marketed device.
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