Medtronic has earned U.S. Food and Drug Administration (FDA) approval for its Simplera continuous glucose monitor (CGM).
 
Simplera is the company’s first disposable, all-in-one CGM. It’s half the size of prior Medtronic CGMs. Its design simplifies insertion and wear, according to Medtronic, removing the need for overtape. The Simplera CGM earned CE mark approval in September 2023.
 
The CGM is designed to be used as part of a Smart MDI system with the InPen smart insulin pen and Simplera Sync sensor. This is integrated with the MiniMed 780G system.
 
Medtronic said the FDA approval paves the way for future submission of the updated InPen smart insulin app, facilitating integration with the Simplera CGM. Once the FDA nod is obtained, the company plans to start limited market release in the U.S., beginning with current standalone CGM and and InPen customers.
 
The Simplera Sync sensor is under FDA review and received EU approval in January.

Partnership to complement future Medtronic CGM offerings

Medtronic also revealed a global partnership with Abbott. The duo plans to 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 for insulin delivery and Smart MDI systems. Medtronic will exclusively sell these systems, which includes the Abbott-based CGM.
 
Financial terms and timing of commercial release were not disclosed.
 
“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. 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,” said Que Dallara, executive VP and president, Medtronic Diabetes.
 
“This partnership pairs two global leaders in glucose sensing technology and insulin delivery,” added Jared Watkin, executive VP of Abbott’s diabetes care business. “Abbott’s CGM technology has set the standard for accurate, accessible, easy-to-use and reliable continuous glucose monitoring. 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.”