Medtronic Diabetes announced FDA 510(k) clearance for its MiniMed Go Smart Multiple Daily Injection (MDI) system. MiniMed Go connects Medtronic’s InPen smart insulin pen with the Instinct CGM through the MiniMed Go app. By combining real-time glucose data with insulin dosing information, the system aims to reduce the daily mental workload of MDI therapy and support more confident dosing decisions.

Key features include missed dose alerts, a built-in dose calculator, and guidance when doses are missed or miscalculated. The system also integrates with CareLink™ software, allowing users and healthcare providers to more easily review trends and therapy data. MiniMed Go is cleared for people with insulin-requiring type 1 and type 2 diabetes ages 7 and older, as well as children ages 2 to 6 under adult supervision.

A key component of MiniMed Go is Abbott’s Instinct sensor, which offers up to 15 days of wear in a slim, discreet form factor. Instinct is the smallest and thinnest integrated CGM in the U.S. market. We recently spoke with Medtronic on the podcast about the Instinct CGM and MiniMed Go, along with broader plans that include spinning out Medtronic Diabetes into a standalone MiniMed company.

Medtronic is also continuing to advance other parts of its diabetes pipeline. The company’s Simplera CGM remains under FDA review for use with MiniMed Go, and Medtronic is separately working on two next-generation insulin pump systems that are expected to further expand its automated and connected insulin delivery portfolio.

Medtronic expects MiniMed Go to begin launching in the U.S. this spring, expanding connected diabetes technology options for people who take injections.

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