FDA Approves New Insulin Sensor

With this approval, the MiniMed 780G system now offers more flexibility for users of the company's most advanced insulin delivery system featuring Meal Detection technology with both the Guardian 4 sensor and Simplera Sync sensor.

The Simplera Sync is a disposable, all-in-one sensor that requires no fingersticks with SmartGuard or overtape and features a simple, two-step insertion process. It is the company's newest addition to its CGM portfolio, which expands options and provides greater flexibility for users.

The MiniMed 780G system's adaptive algorithm automatically anticipates, adjusts, and corrects glucose levels every 5 minutes, 24/7 – working around the clock so users can focus on what matters. It's the only system featuring Meal Detection technology, which detects rising sugar levels and delivers more insulin as needed to help users keep glucose levels in range more often – even when users occasionally forget to dose insulin for snacks or meals or underestimate their carbs. The system uses a "treat to target" approach and flexible glucose targets as low as 100 mg/dL, which, combined with its adaptive algorithm allows it to more closely mirror the glucose levels of someone not living with diabetes. Real-world data of the system shows global users consistently achieve time in range above international targets of 70% when using optimal settings (active insulin time of two hours and 100 mg/dL target glucose). It is also the only system that works with the world's only infusion set that lasts up to 7 days so that users only have to change their infusion set once per week and can experience 96% fewer injections compared to multiple daily injections.

"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."

A limited launch of the Simplera Sync sensor will begin in the U.S. in the fall of 2025. Today, the MiniMed 780G system can be used with the Guardian 4 sensor.

The FDA approval of Medtronic's Simplera Sync sensor for use with the MiniMed 780G insulin pump system does not cancel or negate the prior recall of the MiniMed 600 and 700 series pumps, including the 780G model. The recall, issued in 2024, was due to a critical battery issue where physical impacts could damage internal electrical components, leading to shortened battery life and potential cessation of insulin delivery without adequate warning .​ While the FDA approval enhances the flexibility and options for users of the MiniMed 780G system, it does not address the battery issue that led to the recall. Users should continue to follow Medtronic's guidance regarding the recall, including monitoring battery alerts, carrying spare batteries, and contacting Medtronic if they notice a significant decrease in battery life .