USFDA Approves Simplera CGM

The US Food and Drug Administration (FDA) has approved the Medtronic's Simplera™ Continuous Glucose Monitor (CGM) for Diabetes. Announced on August 7, 2024, the CGM's approval was accompanied by an announcement of a global partnership between Medtronic and Abbott to expand CGM options for individuals with Diabetes.

The Simplera platform featuring the company's newest CGM, 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.

Medtronics and Abbot will collaborate on an integrated CGM based on Abbott's most advanced CGM platform. Abbott will supply Medtronic with a CGM that will work exclusively with Medtronic smart dosing

devices and software across both automated insulin delivery and Smart MDI systems. These systems, including the Abbott-based CGM, will be sold exclusively by Medtronic.

Source: Medtronic plc, 2024