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Wednesday, August 7, 2024

Medtronic FDA approval of Simplera™ CGM and global partnership with Abbott

 Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today 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. 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.

https://www.prnewswire.com/news-releases/medtronic-announces-fda-approval-of-simplera-cgm-and-global-partnership-with-abbott-302216165.html

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