Medtronic (NYSE: MDT) The 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 previous CGMs.
Medtronic The Simplera platform includes the Simplera CGM (designed to be used with the InPen smart insulin pen as part of the Smart MDI system) and the Simplera Sync sensor (designed to be integrated with the MiniMed 780G system).
The Simplera CGM and Simplera Sync sensors have received CE marking in Europe and were launched earlier this year.
The FDA’s approval of Simplera CGM sets the stage for future submission of an updated InPen smart insulin pen app that will facilitate integration with Simplera CGM as a smart MDI system.
Once FDA approval is obtained, Medtronic (MDT) will launch a limited market launch in the United States, initially to existing standalone CGM and InPen customers.
The Simplera Sync sensor is under review by the FDA in a separate regulatory filing. It is undergoing research in the United States and has not yet been approved for commercial use.
In other news, Medtronic (MDT) has entered into a global partnership to offer comprehensive CGM products through a collaboration with Abbott Laboratories (ABT).
