Approval provides more options for users of the automated insulin delivery (AID) system, which can also work with the Guardian 4 sensor.
Simplera Sync, a disposable, all-in-one sensor requires no fingersticks or overtape. It works with SmartGuard technology and features a simple, two-step insertion process.
Medtronic initially won FDA approval in August for its next-generation Simplera CGM. The Simplera platform includes the Simplera CGM for use with the InPen smart insulin pen and Simplera Sync specifically for integration with the MiniMed 780G. The medtech giant picked up CE mark for Simplera Sync with MiniMed 780G in January 2024.
MiniMed 780G offers meal detection technology and provides automatic adjustments and corrections to sugar levels every five minutes. This occurs for both basal (background) and bolus (mealtime) insulin needs.
Medtronic plans to begin a limited Simplera Sync CGM rollout in the fall.
“We’re committed to driving innovation that makes life easier for those living with diabetes so they can forget about their diabetes as much as possible throughout the day,” said Que Dallara, EVP and president of Medtronic Diabetes. “Our MiniMed 780G system delivers advanced diabetes technology for so many around the world, and we’re excited to continue evolving this experience with expanded CGM options —including our Simplera Sync sensor, which we look forward to bringing to people living with diabetes in the U.S.”