Medtronic Gains FDA Clearance for Smart MDI System with InPen™ App and Simplera™ CGM

Medtronic has announced FDA clearance for its updated InPen™ app, introducing missed meal dose detection to support individuals managing diabetes. This milestone paves the way for the launch of Medtronic’s Smart MDI system, which pairs the InPen™ smart insulin pen with the Simplera™ CGM — Medtronic’s first disposable, all-in-one continuous glucose monitor, designed to be half the size of previous models.

The Smart MDI system is the first to provide real-time, personalized dosing recommendations for missed or inaccurate mealtime insulin doses. This innovation addresses a critical need for individuals using multiple daily injection (MDI) therapy, who often miss 1 in 3 insulin doses. By simplifying dosing decisions, the system helps minimize glucose spikes, reducing short- and long-term complications and supporting better health outcomes. Diana Isaacs, PharmD, a certified diabetes care and education specialist, highlighted the impact, stating, “This system represents a significant leap forward, simplifying diabetes management and optimizing long-term health by reducing the guesswork in insulin dosing.”

Medtronic plans a phased release, beginning with existing users of its standalone CGM and InPen™ products, before a broader commercial launch. The Smart MDI system is poised to transform diabetes care, making it easier for users to manage their condition with greater confidence and accuracy.