Medtronic, soon-to-be MiniMed, just landed two big FDA clearances that could reshape its diabetes tech lineup. The first clears its SmartGuard algorithm as an interoperable automated glycemic controller (iAGC), which means it can officially pair with more continuous glucose monitors (CGMs). That sets the stage for integration with Abbott’s upcoming compatible Instinct CGM. In the same week, the FDA also approved the MiniMed 780G system for adults with insulin-requiring type 2 diabetes in the U.S.

Let’s start with the upcoming Instinct CGM. The sensor will be built by Abbott but exclusively used with MiniMed insulin pumps. Medtronic has confirmed the Instinct will have a 15-day wear time, matching Abbott’s Libre 3 Plus. That marks a big leap from Guardian sensors and its latest Simplera CGM, which have been limited to shorter wear time. While clearance is a major milestone, commercial rollout will depend on manufacturing readiness (we hear production is already ramping up with an expected release in early 2026). The final step is for Medtronic and Abbott to complete their compliance documentation, enabling full sensor integration and marketing. Once this is done, the regulatory process will be complete.

Back in August, Medtronic teased Instinct on social media with a Libre-like design that looks tailored for its next generation of hardware. The sensor is expected to pair with the MiniMed Fit and MiniMed Flex pumps currently in development.

Meanwhile, the company’s disposable 7-day sensor, Simplera, has struggled with supply shortages in Europe, raising questions about its future in the portfolio. Instinct could be the pivot point that allows Medtronic to compete head-to-head with Dexcom and Abbott sensors already powering other AID systems.

The second approval may prove just as important. The FDA cleared the MiniMed 780G for adults with insulin-requiring type 2 diabetes, ages 18 and older. Until now, the system was limited to type 1s. This expansion broadens its potential reach to an estimated 3–4 million U.S. adults with type 2 who use insulin, though adoption could be modest without strong payer coverage. Still, for many providers and patients, it offers another automated option in a space that has historically been underserved. Competitors Tandem and Insulet already hold type 2 clearances.

Two approvals in the same week signal that Medtronic is positioning for a comeback. The real question is whether Instinct and the expanded 780G can deliver the scale and reliability users are hoping for. Would you try Instinct or 780G with these new updates? Let me know what you think in the comments below.

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