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FDA Clears Medtronic's InPen App, Advancing Smart MDI System Launch

• The FDA has cleared Medtronic's InPen app, which features missed meal dose detection, a crucial step for launching its Smart MDI system. • The Smart MDI system integrates the InPen smart insulin pen with Simplera, Medtronic's continuous glucose monitor (CGM), approved by the FDA in August. • Medtronic plans a limited market release of the Smart MDI system, starting with current CGM and InPen users, followed by a wider commercial launch.

Medtronic has announced that the U.S. Food and Drug Administration (FDA) has cleared its InPen app, which includes a new feature for missed meal dose detection. This clearance is a significant milestone, paving the way for the launch of Medtronic's Smart MDI (Multiple Daily Injections) system, which integrates continuous glucose monitoring (CGM) capabilities.
The Smart MDI system combines the InPen smart insulin pen with Simplera, Medtronic's CGM system that was approved by the FDA in August. This integration aims to simplify diabetes management for patients who require insulin injections. The InPen app's new feature is designed to help users track and manage their insulin doses more effectively, particularly in relation to meal times.
Medtronic plans to initiate a limited market release of the Smart MDI system, beginning with existing users of its standalone CGM and InPen devices. Following this initial phase, a broader commercial launch is planned. The company anticipates that the integrated system will offer improved convenience and glycemic control for individuals managing their diabetes with multiple daily insulin injections.
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Reference News

[1]
Medtronic Says FDA Clears InPen App, Clearing Path for Glucose Monitoring System Launch
morningstar.com · Nov 20, 2024

Medtronic's Smart MDI system with continuous glucose monitoring is nearing launch after FDA clearance of the InPen app, ...

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