Medtronic Receives FDA Clearance for Smart MDI System with New InPen App

On November 20, 2024, Medtronic received FDA clearance for its latest InPen app.

This advancement sets the stage for the launch of Medtronic’s Smart MDI system, which pairs the innovative app with the new Simplera continuous glucose monitor (CGM).

A Breakthrough in Real-Time Insulin Dosing

The Medtronic Smart MDI system is the first to provide real-time, personalized dosing recommendations, addressing missed or inaccurate mealtime insulin doses.

For people managing diabetes through multiple daily injections, this system simplifies daily decisions while supporting better blood sugar control.

Key features include:

• Missed Meal Dose Alerts: Helps users avoid blood sugar spikes by detecting skipped doses.
• Simplera CGM: Medtronic’s first disposable, all-in-one CGM is half the size of previous models, offering discreet, convenient glucose monitoring.
• Enhanced Insights: Delivers personalized recommendations to maintain stable glucose levels and reduce complications.

Why This Matters for People with Diabetes

Insulin dosing is critical for preventing glucose highs and lows, yet studies show that one in three doses is missed.

Insulin dosing is critical for preventing glucose highs and lows, yet studies show that one in three doses is missed.

The Smart MDI system minimizes this challenge by offering real-time support, which can reduce the risk of long-term complications like heart disease or nerve damage.

Diana Isaacs, PharmD, a leading diabetes care expert, emphasized the importance of this development.

“By reducing the guesswork out of insulin dosing, this tool helps maintain stable blood sugars, optimize long-term health, and reduce complications from hyperglycemia.”

What This Means for Diabetes Care

This innovative system promises a simpler, smarter way for MDI users to manage their diabetes, empowering them to live healthier, more confident lives.

Launch Details

Medtronic will begin a limited market release with existing InPen and Simplera users, followed by a full commercial launch.