Medtronic Claims 'World's First' Approval for Disposable, All-in-One CGM

It requires no fingersticks or overtape.

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Medtronic announced CE (ConformitĂ© EuropĂ©enne) Mark approval for the MiniMed 780G system with Simplera Sync, a disposable, all-in-one continuous glucose monitor (CGM) requiring no fingersticks or overtape. Simplera Sync features an improved user experience with a simple, two-step insertion process and is half the size of previous Medtronic sensors.

The MiniMed 780G system with Simplera Sync sensor will be available in Europe via limited release in spring 2024. Medtronic will begin the phased commercial launch in Europe in the summer of 2024. Today, the MiniMed 780G system can be used with the Guardian 4 sensor.

The MiniMed 780G system is Medtronic's most advanced insulin delivery system, automatically adjusting and correcting glucose levels every 5 minutes. It's the world's only system with a Meal Detection feature that is designed to reduce post-meal hyperglycemia when users occasionally forget to give themselves insulin or underestimate the number of carbs in their snacks or meal. The system, which is available with the world's only 7-day infusion set, also features one of the lowest glucose target settings (as low as 100 mg/dL) of any automated insulin delivery system. With this "treat to target" approach, the system more closely mirrors the glucose levels of someone not living with diabetes. With both Simplera Sync sensor and the Guardian 4 sensor, no fingersticks are required.

The MiniMed 780G system with Simplera Sync sensor is indicated for ages 7+ and compatible with iOS and Android. Simplera Sync sensor is not approved by the FDA and is limited to investigational use in the U.S.

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