Medtronic has submitted its next-generation tubed insulin pump, MiniMed Flex, to the U.S. FDA, setting the pump one step closer to release.

The MiniMed Flex is designed to be smaller and more discreet than the current 780G system while continuing to use the same reservoirs and infusion sets. The pump which closely resembles a vape pen has no screen and is controlled entirely from a phone. The pump will integrate with Medtronic’s line of continuous glucose monitros — Simplera Sync and Instinct, expanding compatibility within its ecosystem. It is expected that the Fit will eventually replace the current MiniMed 780G pump. The FDA submission aligns with the company’s previously stated development timeline.

In addition to the new pump, Medtronic has launched a U.S. pivotal study for Vivera, its third-generation automated insulin delivery (AID) algorithm aimed at further improving glucose control through advanced software. The company also plans to submit a patch pump, called MiniMed Fit, for regulatory review later this year.

Medtronic continues progressing toward spinning off its diabetes division into an independent company, to be named MiniMed. The planned separation, structured as an IPO followed by a split, is expected to be completed by the end of 2026, positioning the new entity to focus exclusively on diabetes innovation.

What do you think of Medtronic’s upcoming pump lineup? Let us know in the comments!

Disclaimer: Diabetech content is not medical advice—it’s for educational purposes only. Always consult with a physician before making changes to your healthcare.