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Medtronic Submits Interoperable Insulin Pump to FDA to Grow Partnership with Abbott

The FDA nod will facilitate system integration with a continuous glucose monitoring (CGM) sensor based on Abbott’s most advanced CGM platform.

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By: Sam Brusco

Associate Editor

Medtronic has submitted 510(k) applications to the U.S. Food and Drug Administration seeking clearance for an interoperable insulin pump. The FDA nod will facilitate system integration with a continuous glucose monitoring (CGM) sensor based on Abbott’s most advanced CGM platform.

The submissions included a 510(k) submission to the FDA for Medtronic’s MiniMed 780G pump as an alternate controller enabled (ACE) insulin pump and a separate application for its SmartGuard algorithm as an interoperable automated glycemic controller (iAGC).

This follows an announcement last August that the companies will partner on an integrated system based on Abbott’s most advanced CGM platform. Abbott will supply Medtronic with a CGM that will work exclusively with Medtronic smart dosing devices and software for both automated insulin delivery and smart multiple daily injections systems.

These systems, including the Abbott CGM, will be sold exclusively by Medtronic.

“We understand how meaningful these advancements are, and we’re working with urgency to bring enhanced CGM options to our customers,” said Que Dallara, EVP & president, Medtronic Diabetes. “This collaboration with Abbott marks an important step forward in providing innovative solutions and more choice for our customers.”

The company said that more details will be shared when FDA clearance is obtained.

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