August 9, 2024- Medtronic plc 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 Simplera™ CGM and Simplera Sync™ sensor are CE Marked in Europe and launched earlier this year with positive feedback around ease of use and insertion, adding to the existing high satisfaction 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. Once FDA clearance is obtained, Medtronic will initiate a limited market release in the U.S. beginning with existing standalone CGM and InPen™ customers.