Medtronic wins FDA approval for Simplera CGM

Medtronic’s (NYSE:MDT) Simplera continuous glucose monitor (CGM) has received regulatory approval from the U.S. Food and Drug Administration (FDA).

Simplera is the company’s first disposable, all-in-one continuous glucose monitor that is half the size of its previous CGMs.

The Medtronic Simplera platform 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.

The 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 (MDT) 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.

In other news, Medtronic (MDT) entered a global partnership to offer an integrated CGM offering through a collaboration with Abbott (ABT).