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• FDA grants approval for Medtronic’s (MDT, Financial) new Simplera Sync™ sensor for MiniMed™ 780G system.
• New sensor promises no fingerstick requirement and simplified insertion process.
• U.S. launch set for fall 2025.

Medtronic (MDT) has received U.S. FDA approval for its latest innovation, the Simplera Sync™ sensor, tailored for use with the MiniMed™ 780G system. This new addition to Medtronic’s continuous glucose monitoring (CGM) portfolio is a disposable, all-in-one sensor that stands out with its ability to operate without requiring fingersticks, thanks to the SmartGuard™ technology. The sensor is designed with a simplified two-step insertion process, enhancing ease of use for patients.

The MiniMed™ 780G system boasts an adaptive algorithm that automatically adjusts and corrects glucose levels every five minutes, utilizing Meal Detection™ technology. In real-world applications, this system helps users maintain glucose levels in the target range over 70% of the time when using optimal settings. Moreover, Medtronic’s system utilizes a unique 7-day infusion set, significantly reducing injection frequency by 96% compared to routine daily injections.

The U.S. rollout of the Simplera Sync™ sensor is anticipated for the fall of 2025, reflecting a strategic phased introduction. Currently, the MiniMed™ 780G system uses the Guardian™ 4 sensor, but the approval of the Simplera Sync™ sensor provides users with greater flexibility and choice within Medtronic’s diabetes management ecosystem. This development strengthens Medtronic’s position in the competitive CGM market, aligning with the company’s commitment to innovating diabetes care solutions.