Medtronic Advances Diabetes Management with FDA Clearance of InPen App and Launch of Smart MDI System

FDA Clearance:
Medtronic has received FDA clearance for its InPen smartphone app, a crucial component of its Smart MDI system designed for individuals on multiple daily injection (MDI) therapy[1].

Smart MDI System:
The Smart MDI system includes the InPen smart insulin pen, the InPen app, and Medtronic’s Simplera continuous glucose monitor (CGM), which was approved by the FDA in August 2024[1][3].

Simplera CGM:
The Simplera CGM is a disposable, all-in-one device that simplifies the insertion and wear experience, eliminating the need for overtape[3].

Partnership with Abbott:
Medtronic has announced a global partnership with Abbott to develop a new CGM that will use Abbott’s FreeStyle Libre sensors and work exclusively with Medtronic’s smart insulin delivery systems and software[1][3].

Launch Strategy:
Medtronic is starting with a soft launch focused on existing CGM and InPen customers, followed by a more extensive commercial launch[1].

Clinical Benefits:
The Smart MDI system aims to provide real-time insights and simplify diabetes management by reducing the guesswork out of insulin dosing, helping maintain stable blood sugars, and optimizing long-term health[1].