Medtronic seeks FDA approval for insulin pump, furthering Abbott collab

Medtronic is pursuing FDA clearance to make its MiniMed 780G insulin pump compatible with Abbott’s continuous glucose monitors (CGMs), advancing their collaboration in diabetes technology. The company submitted two 510(k) applications: one to classify the 780G as an alternate controller enabled (ACE) pump, and another to designate its SmartGuard algorithm as an interoperable automated glycemic controller (iAGC). Approval would enable Medtronic’s pump and algorithm to function within an automated insulin delivery (AID) system using third-party glucose sensors. Traditionally, Medtronic has only paired its pumps with its own CGMs. However, Abbott, a leading CGM manufacturer, has already partnered with other insulin pump makers such as Tandem, Insulet, and Beta Bionics. In 2023, Abbott and Medtronic agreed that Abbott would produce CGMs specifically for Medtronic’s pumps and pens, while Medtronic would distribute them. Meanwhile, Medtronic continues developing its own sensors, including the FDA-approved Simplera Sync, now integrated with the MiniMed 780G system.

28-04-2025