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FDA Clears Medtronic's InPen App for Smart MDI System with Simplera CGM

• Medtronic receives FDA clearance for its updated InPen app, designed for use with the Simplera CGM system, enhancing its smart multiple daily injection (MDI) system. • The InPen system is the first smart MDI system capable of recommending corrections for missed or inaccurate insulin doses, offering personalized insights. • This integration aims to reduce the complexities of diabetes management for MDI users by providing real-time support for insulin dosing decisions. • The clearance supports the launch of Medtronic's next-generation Simplera CGM, offering a comprehensive solution for individuals on MDI therapy.

Medtronic has secured FDA clearance for its new InPen insulin delivery system application, paving the way for the launch of its smart multiple daily injection (MDI) system. This system integrates with the recently FDA-cleared, next-generation Simplera continuous glucose monitor (CGM).
The InPen system stands out as the first on the market to recommend corrections for missed or inaccurate insulin doses. It aims to provide real-time, personalized insights for individuals on MDI therapy, addressing the challenges they face in daily insulin dosing decisions. Medtronic emphasizes that this smart MDI system is designed to reduce the guesswork involved in diabetes management, meeting a critical unmet need for MDI users.
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Reference News

[1]
Medtronic wins FDA nod for new InPen app to support launch with Simplera CGM
massdevice.com · Nov 20, 2024

Medtronic receives FDA clearance for InPen app, enabling launch of smart MDI system with Simplera CGM, offering real-tim...

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