Medtronic Gets FDA OK for New Insulin Pump Sensor

Medtronic announced FDA approval for the Simplera Sync sensor for use with the MiniMed 780G system. With this approval, the MiniMed 780G system now offers more flexibility for users of the company's 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 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. It features Meal Detection technology, which detects rising sugar levels and delivers more insulin as needed to help users keep glucose levels in range more often.

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.

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.