
Medtronic Receives CE Mark For New Simplera Continuous Glucose Monitoring System
Medtronic, a leading healthcare technology company, has received CE Mark approval for its new Simplera continuous glucose monitor (CGM). This all-in-one disposable CGM offers a straightforward two-step insertion process and eliminates the need for over tape. It also offers seamless integration with the InPen smart insulin pen, providing real-time, personalized dosing guidance to simplify diabetes management. It also is half the size of Medtronic’s currently offered Guardian Connect System. The phased launch of Simplera is set to commence at the European Association for the Study of Diabetes (EASD) 59th Annual Meeting in Hamburg, Germany, from October 2 to 6, 2023. This innovative system aims to assist patients in managing their diabetes by offering personalized guidance and reducing the complexity of their daily routines.
Dr. Sandra Schlüter, an endocrinologist from Germany and the Head of AGDF, highlighted the significance of this solution for overwhelmed diabetes patients. She praised Medtronic for providing real-time personalized guidance, making diabetes management more accessible and offering peace of mind. Despite the widespread adoption of CGM over the past decade, fewer than 30% of individuals using a CGM alongside MDI therapy achieve glycemic targets, emphasizing the unmet need in this field. Que Dallara, EVP and President of Medtronic Diabetes, expressed excitement about helping more people reach their diabetes management goals with the InPen powered by Simplera, which represents Medtronic’s commitment to simplifying life for individuals with diabetes. Simplera is designed for ages 2 and above, compatible with iOS and Android, and not yet approved by the FDA, making it limited to investigational use in the United States. Additionally, Medtronic’s automated insulin delivery (AID) system integrated with this sensor is under review for CE Mark approval and is not yet available for commercial use in the U.S. or Europe.
Simplera will enhance Medtronic’s competitive offering against other major CGM companies including Insulet, Dexcom, Abbott, Senseonics, and Roche.