Medtronic Secures FDA Approval for Simplera CGM, Partners with Abbott

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has approved the Simplera™ continuous glucose monitor (CGM) for diabetes from Medtronic, the company’s first disposable, all-in-one device half the size of previous offerings.

Announced on August 7, 2024, the CGM's approval was accompanied by the introduction of a global partnership with Abbott to expand CGM options for individuals with diabetes. Under this agreement, the companies will collaborate on an integrated CGM based on Abbott’s advanced platform.

“Our partnership with Abbott allows us to expand access to our advanced automated insulin delivery and Smart MDI systems that deliver best-in-class outcomes with the most widely used CGM in the world,” said Que Dallara, executive vice president and president, Medtronic Diabetes. “We look forward to offering our Simplera™ platform alongside this integrated CGM to bring more choice to people living with diabetes within one seamless Medtronic experience.”

Medtronic’s Simplera™ platform features the company’s latest CGM form factor, designed to be used as part of a Smart MDI system with the InPen™ smart insulin pen and the Simplera Sync™ sensor, designed to be integrated with the MiniMed™ 780G system.

FDA approval for the Simplera™ CGM provides an in-road for the future submission of the updated InPen™ smart insulin pen app, which would facilitate integration as a Smart MDI system. Pending FDA clearance, a limited market release will be initiated with existing standalone CGM and InPen™ users.

Medtronic indicated the Simplera Sync™ sensor is also under review by the FDA in a separate regulatory filing and is not approved for commercial use. The Simplera™ CGM and Simplera Sync™ are CE Marked in Europe, with launch earlier this year and positive feedback on the ease of use and insertion.

Further global regulatory submissions and approvals of the Simplera™ CGM and Simplera Sync™ sensor are pending.

Under the global partnership, 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. Medtronic will exclusively sell these systems, including the Abbott-based CGM.

“Abbott’s CGM technology has set the standard for accurate, accessible, easy-to-use, and reliable continuous glucose monitoring,” said Jared Watkin, executive vice president, Abbott’s diabetes care business. “Connecting this CGM built for Medtronic’s advanced insulin delivery systems and algorithms makes it easier for people to spend less time thinking about their diabetes and more time living.”

References

_{Medtronic announces FDA approval of SimpleraTM CGM and Global Partnership with Abbott. Medtronic News. August 7, 2024. Accessed August 7, 2024. https://news.medtronic.com/2024-08-07-Medtronic-announces-FDA-approval-of-Simplera-TM-CGM-and-global-partnership-with-Abbott.}