Medtronic announces US FDA approval of ‘Simplera’ CGM

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Medtronic announced the U.S. Food and Drug Administration (FDA) approval for its Simplera continuous glucose monitor (CGM) — the company's first disposable, all-in-one CGM that's half the size of previous Medtronic CGMs. The discreet design simplifies the insertion and wear experience, eliminating the need for overtape.

The Simplera platform featuring the company's newest CGM form factor, includes the Simplera CGM, designed to be used as part of a Smart MDI system with the InPen smart insulin pen and the Simplera Sync sensor, which is designed to be integrated with the MiniMed 780G system.

The recent FDA approval for Simplera CGM lays the groundwork for future submission of the updated InPen smart insulin pen app, which would facilitate integration with Simplera CGM, as a Smart MDI system. The Simplera Sync sensor is under review by the FDA in a separate regulatory filing. It is investigational in the U.S. and not approved for commercial use.

Additional global regulatory submissions and approvals of the Simplera CGM and Simplera Sync sensor are pending.