Medtronic has earned U.S. Food and Drug Administration (FDA) approval for its Simplera Sync continuous glucose monitor (CGM) for use with the MiniMed 780G insulin delivery system.

Simplera Sync is a disposable, all-in-one sensor that requires no fingersticks with SmartGuard or overtape. It also has a simple, two-step insertion process, according to the company.

MiniMed 780G’s adaptive algorithm automatically anticipates, adjusts, and corrects glucose levels every five minutes. It features Meal Detection technology, which detects rising sugar levels and delivers more insulin as needed to keep glucose levels in range—even when users forget to dose insulin for snacks or meals or underestimate their carbs.

A “treat to target” approach and flexible glucose targets as low as 100 mg/dL, combined with and adaptive algorithm, lets MiniMed 780G more closely mirror glucose levels of someone without diabetes. Its infusion set lasts up to seven days, meaning users experience 96% fewer injections compared to multiple daily injections.

Simplera Sync will undergo limited launch in the U.S. in fall 2025. MiniMed 780G with the Simplera Sync CGM launched in the EU in spring 2024.

“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.”