Medtronic reaffirmed its next-generation insulin delivery systems remain on track, highlighting progress across its upcoming MiniMed Flex tubed pump, MiniMed Fit patch pump, and expanding sensor portfolio.

During its second-quarter earnings call, the company said it is still on pace to submit the MiniMed Flex (8 series) durable AID pump to the U.S. FDA by the end of its fiscal year in April 2026. Flex is designed to be significantly smaller than the MiniMed 780G, without a screen, while maintaining compatibility with existing reservoirs and infusion sets. It will also integrate with Medtronic’s latest sensors, the Simplera Sync and Instinct continuous glucose monitors (CGM).

The company is also developing a tubeless patch style system, the MiniMed Fit, with FDA submission expected in fall 2026. Fit enters an increasingly competitive patch pump category that includes Insulet’s Omnipod and planned entries from Tandem, Beta Bionics, ViCentra, and PharmaSens. Fit will share the same algorithm and sensor ecosystem as Flex, helping coordinate development timelines.

Medtronic also reported progress on its Vivera algorithm, which will power both devices. Vivera has now received FDA clearance to begin its pivotal trial, keeping its timeline in step with the two pump submissions.

Medtronic reiterated that its key diabetes programs are progressing as planned and that the MiniMed separation remains on course for completion by the end of 2026, with product development moving forward uninterrupted.

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