Medtronic Receives FDA Approval for Simplera Sync CGM Integration with MiniMed 780G Insulin Pump

Medtronic Announces Its Latest CGM Product ---SimpleraFDA Approval Received for Use with Its Most Advanced Insulin PumpMiniMed 780GUse in conjunction. Following this approval, equipped withMeal Detection TechnologyTheMiniMed 780GWill provide users with more flexible choices, compatible with Guardian 4 or selectable for use.Simplera。

Executive Evaluation

"We are committed to reducing the daily management burden for people with diabetes through innovative technology. The MiniMed 780G has provided advanced solutions for tens of thousands of patients, and the addition of Simplera will further enhance the CGM user experience. We look forward to bringing this revolutionary product to people with diabetes in the United States as soon as possible."

---Que Dallara  Executive Vice President and President of Medtronic Diabetes Division

MiniMed 780G+SimpleraIt is currently the best diabetes treatment technology that Medtronic can offer to diabetic patients. It is also the best insulin and CGM product that Medtronic has available. According to Medtronic's Q3 2025 financial report:SimpleraAndMiniMed 780GPromote MedtronicThe main driver of diabetes business growth (Q3: revenue of $6.94 billion, organic growth of 10.4%). Now, with the combination of two flagship products, it will not only bring better treatment for diabetes but also drive Medtronic's development.Diabetes business grows rapidly.

However, the market is more looking forward to the strong combination of Medtronic and Abbott's top products, which took place in the middle of last year.Medtronic and Abbott Jointly Announce In-Depth Collaboration in Diabetes Field, Featuring Leading CGM ProductsFreeStyle Libre Integrated into Medtronic'sAutomatic Insulin Delivery (AID) and Smart Insulin Pens Create a 1+1>2 Effect.

If the two companies cooperate sincerely, it is estimated that results will be seen within the next two years.MiniMed 780G+The combination of FreeStyle Libre3 will bring rapid growth to Medtronic's diabetes business.

MiniMed 780G+Simplera

• Simplera

SimpleraTwo Major Technological Innovations:

Painless Experience Upgrade: Fully eliminate fingertip calibration through SmartGuard technology, without the need for adhesive tape.

Minimalist Operation Design: Adopting a two-step insertion process, the ease of use has significantly improved. As the latest member of Medtronic's Continuous Glucose Monitoring (CGM) product line, Simplera further expands the diversity of diabetes management solutions.

• MiniMed 780G

MiniMed 780GThe adaptive algorithm automatically predicts, adjusts, and corrects blood glucose levels every 5 minutes, operating continuously 24/7, allowing patients to focus more on their lives.

Its exclusive advantages include:

Intelligent Dietary Response: Equipped with the world's only Food Detection™ technology‡, it can automatically identify blood glucose rising trends and adjust insulin infusion in real time. Even if patients occasionally forget pre-meal injections or underestimate carbohydrate intake, it can still help them maintain target blood glucose levels for a longer period.

New Standard for Precise Blood Sugar Control: Adopting a "targeted therapy" strategy, supporting flexible blood glucose target settings as low as 100mg/dL, combined with adaptive algorithms to simulate physiological blood glucose fluctuations in healthy individuals.

Proven Excellent Efficacy: Global real-world data shows that, under optimized settings (2-hour active insulin time + 100 mg/dL target value), users' Time in Range (TIR) consistently exceeds the international standard of 70%.

Breakthrough in Long-Acting Infusion: Used in conjunction with the world's only infusion set that can be continuously worn for 7 days, requiring replacement only once a week, reducing injection frequency by 96% compared to traditional multiple daily injections.