Medtronic's FDA Submission for Insulin Pump
Medtronic plc announced it has submitted 510(k) applications to the FDA seeking clearance for an interoperable pump. FDA clearance of this pump would pave the way for system integration with a continuous glucose monitoring (CGM) sensor based on Abbott's most advanced CGM platform.
The submissions included a 510(k) application for its MiniMed 780G pump as an alternate controller enabled (ACE) insulin pump and a separate 510(k) application for its SmartGuard algorithm as an interoperable automated glycemic controller (iAGC).
"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."
This milestone follows the announcement last August that the companies will collaborate 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 across both automated insulin delivery and smart multiple daily injections systems. These systems, including the Abbott CGM, will be sold exclusively by Medtronic.
More details will be shared when FDA clearance is secured.
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