Medtronic gets USFDA nod for Simplera Sync sensor for MiniMed 780G System
Medtronic plc has announced the U.S. Food and Drug Administration (FDA) has approved 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 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 a 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). The system also 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.
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