Medtronic has taken a significant step by submitting 510(k) applications to the FDA for its MiniMed™ 780G pump and SmartGuard™ algorithm. These submissions aim to secure clearance for the devices to function as an ACE insulin pump and an insulin automated glycemic controller (iAGC), respectively, which allows them to operate in tandem with Abbott's continuous glucose monitoring (CGM) systems.
According to Insider Monkey, this move is part of a broader collaboration announced in 2024 between Medtronic and Abbott, which integrates Abbott’s FreeStyle Libre technology with Medtronic’s advanced automation in insulin delivery and smart pens. In a competitive market where choice is critical, Medtronic will maintain exclusive marketing rights for these integrated systems, combining its insulin dosing devices and software with Abbott’s CGM.
This strategic submission follows Medtronic’s recent FDA approval for its Simplera Sync™ CGM, integrated with the MiniMed 780G system. Medtronic's aim is to broaden the options available for diabetes management, potentially increasing accessibility and market share for both Medtronic and Abbott in the diabetes care sector.