FDA approves Medtronic’s Simplera Sync Sensor for use with MiniMed 780G Insulin System

FDA approves Medtronic's sensor: ©Medtronic

Medtronic plc (NYSE: MDT), a health care technology company, announced that the U.S. Food and Drug Administrationhas approved its Simplera Sync continuous glucose monitoring (CGM) sensor for use with the MiniMed 780G insulin delivery system.

The approval gives users of the MiniMed system a new CGM option, expanding flexibility for people managing diabetes. The system, which already works with the Guardian 4 sensor, can now also integrate with the Simplera Sync sensor—an all-in-one, disposable sensor that requires no fingersticks or overtape and features a simplified two-step insertion process.

"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, executive vice president 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."

The MiniMed 780G system uses an adaptive algorithm to automatically adjust and correct glucose levels every five minutes around the clock. It features proprietary meal detection technology, which detects rising glucose levels and can deliver additional insulin to help keep users in range—even when meals or snacks are missed or undercounted.

Medtronic touts the system’s “treat to target” approach with customizable glucose targets as low as 100 mg/dL. Real-world data shows users who apply optimal settings achieve time-in-range above international goals of 70%.

The MiniMed 780G also works with the world’s only insulin infusion set that can last up to seven days, reducing the frequency of needle insertions by up to 96% compared to multiple daily injections.

A limited U.S. launch of the Simplera Sync sensor is planned for fall 2025.