FX.co ★ Medtronic Says FDA Clearance For New InPen App

Medtronic plc, a healthcare technology company, has announced the U.S. Food and Drug Administration's (FDA) approval for its latest InPen app, which features a missed meal dose detection capability. This approval marks a significant step toward releasing its Smart MDI system, integrated with the Simplera continuous glucose monitor (CGM).

This innovative system merges Medtronic's InPen smart insulin pen with the Simplera CGM, its pioneering disposable and compact CGM device, which is notably reduced in size to half that of previous models.

With FDA clearance, the Smart MDI system becomes the first in the market to offer real-time, personalized recommendations on insulin dosing, including corrections for missed or inaccurately administered mealtime doses. It aims to support individuals using multiple daily injection (MDI) therapy by suggesting corrective actions for dose inaccuracies.

The system's Missed Dose alert functionality is designed to limit the occurrence of glucose spikes, thereby decreasing the complexities of managing diabetes. This addresses a critical challenge faced by MDI users, who often struggle with numerous daily insulin dosing decisions.

Medtronic plans to commence a limited market release, initially targeting existing standalone CGM and InPen customers, before proceeding with a broader commercial rollout.