Medtronic announced U.S. Food and Drug Administration 510(k) clearance for its MiniMed Go™ Smart Multiple Daily Injection (MDI) system on January 12, 2026. The system integrates the InPen™ smart insulin pen with Abbott’s Instinct continuous glucose monitoring sensor into a single mobile app. This approval marks the first FDA-cleared solution to unify insulin dosing data and real-time glucose readings for patients on multiple daily injections, enabling automated dose calculations, missed-dose alerts and care-team reporting via CareLink™ software.

More than 15 million people worldwide rely on multiple daily injections for diabetes management, and real-world data from 1,852 users of Medtronic’s prior Smart MDI system showed that addressing over 75% of missed-dose alerts within one hour raised Time in Range (TIR) from 55.7% to 67.2%, climbing to 71.5% when high-glucose alerts prompted a timely bolus. Skipping as few as two doses per week can elevate HbA1c by 0.4%, underscoring the system’s potential to reduce glycemic variability and long-term complication risk.

The MiniMed Go™ system is cleared for use in individuals aged seven and older with type 1 or type 2 diabetes and for children aged two to six under adult supervision. Simplera™ sensor compatibility is under FDA review. Medtronic plans a U.S. commercial launch in spring 2026, positioning the product to address diabetes distress associated with meal-time dosing calculations across pediatric and adult patient segments.

By extending its full-stack insulin delivery portfolio beyond pump-based automated systems, Medtronic aims to capture the growing segment of pen-users seeking smart dosing support. Que Dallara, EVP and president of Medtronic Diabetes, emphasized that MiniMed Go™ brings advanced algorithm-driven guidance to pen therapy, strengthening the company’s leadership in integrated diabetes management and supporting physician collaboration through cloud-based data sharing.