Medtronic Enters CGM Market with FDA Approval of Simplera Sync™ for MiniMed™ 780G System

Following its approval in Europe early last year, Medtronic has recently received permission from the U.S. Food and Drug Administration (FDA) for its latest automated insulin pump, the MiniMed 780G, to be technically integrated with the new continuous glucose monitoring system, the Simplera Sync™ sensor.

It is reported that the sensor of Simplera Sync is a disposable, all-in-one wearable continuous glucose monitoring (CGM) system. Its main feature is that it basically does not require fingerstick blood sampling or the use of auxiliary tapes. The implantation process only involves two steps and does not require SmartGuard™ or additional patches for fingerstick blood sampling.

The design highlight of the Simplera Sync monitoring system lies in its 50% reduction in size compared to the previous generation, with subcutaneous implantation completed within 10 seconds. The system retains the core architecture of its predecessor, the Simplera CGM, which received separate FDA approval in August last year as a component of Medtronic’s multi-dose injection system, used in conjunction with smart insulin pens.

According to the plan, after the official launch of this product in the U.S. market this fall, it will achieve system integration with Medtronic's MiniMed 780G insulin pump. Currently, patients with diabetes need to use this insulin pump in conjunction with the company’s Guardian 4 sensor.

MiniMed 780G Insulin Pump System Receives FDA Approval in April 2023: Adaptive Algorithm Automatically Predicts, Adjusts, and Corrects Glucose Levels Every 5 Minutes, Operating 24/7. This system is currently the only one utilizing meal detection technology, which monitors rising glucose levels and administers additional insulin when necessary, helping users maintain glucose within target ranges—even if they occasionally forget to administer insulin at mealtimes or underestimate carbohydrate intake. The system employs a "goal-oriented" treatment approach with flexible glucose targets as low as 100 mg/dL. Combined with its adaptive algorithm, the system achieves more precise simulation of non-diabetic glucose levels.

Notably, Medtronic announced a global strategic partnership with Abbott during the same period. Under the agreement, Abbott will develop a dedicated integrated continuous glucose monitoring system based on its FreeStyle Libre technology platform. This product will serve as an exclusive accessory, ensuring technical compatibility with Medtronic's insulin delivery systems.

Editor: Mu Mian

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