Core Insights - Medtronic plc has received CE Mark approval in Europe to expand the indications for the MiniMed™ 780G system, allowing its use for individuals aged 2 years and older, during pregnancy, and for those with type 2 diabetes [1] Group 1: Expanded Indications - The MiniMed™ 780G system is now indicated for children aged 2-6 years with type 1 diabetes, showing a 0.6% reduction in HbA1C and a 9.9% increase in time in range when used in auto mode compared to manual mode [2] - The system has been recognized as a standard of care for children with type 1 diabetes across Europe, with guidelines from NICE and the German Diabetes Association recommending its use [3][4] Group 2: Pregnancy Management - The MiniMed™ 780G system offers significant benefits for managing type 1 diabetes during pregnancy, achieving an average Pregnancy Time in Range (TIRp) of 66.5%, which is an improvement over traditional insulin therapy [6] - Clinical guidelines emphasize the importance of tighter glucose control during pregnancy, with the MiniMed™ 780G system providing better overnight glucose control and higher treatment satisfaction among expectant mothers [5][6] Group 3: Type 2 Diabetes Indication - The MiniMed™ 780G system is now also approved for individuals with type 2 diabetes, demonstrating a 0.7% reduction in HbA1c and an increase in time in range to 80% in a pivotal trial [7] - Real-world data from 26,427 users with type 2 diabetes showed good glycemic control, exceeding the international consensus of 70% time in range [7] Group 4: Future Developments - Medtronic is working with U.S. regulatory authorities to expand the use of the MiniMed™ 780G system for individuals with type 2 diabetes, with ongoing clinical trials for children aged 2-6 years [8]

Core Insights - Medtronic plc announced the name "MiniMed" for its planned new Diabetes Company, honoring its legacy and 40-year history in diabetes care [1] - The company aims to enhance diabetes management through innovative technology, making it more predictable and less burdensome for patients [1][2] - The separation of the Diabetes business is targeted for completion within 18 months, subject to legal and customary conditions [3] Company Overview - Medtronic is a global leader in healthcare technology, focusing on transforming diabetes care [1] - The Diabetes business employs over 8,000 individuals dedicated to innovation and improving health outcomes for diabetes patients [2] Historical Context - MiniMed was originally founded in 1983 by Alfred E. Mann, introducing groundbreaking innovations in diabetes care [1] - The name change reflects the company's commitment to its roots and the trust built over decades [1] Future Plans - The separation will involve capital markets transactions, potentially including a spin-off or split-off of the remaining shareholding in MiniMed [5] - The company is committed to fulfilling its mission of making diabetes management more stable and predictable [1][2]

Core Insights - Medtronic has received FDA approval for the Simplera Sync™ sensor, enhancing the MiniMed™ 780G system's capabilities in the U.S. market [1][3] - The Simplera Sync™ sensor is a disposable, all-in-one device that eliminates the need for fingersticks and simplifies the insertion process, providing greater flexibility for users [2][6] - The MiniMed™ 780G system features an adaptive algorithm that adjusts glucose levels every 5 minutes, utilizing Meal Detection™ technology to optimize insulin delivery [2][3] Product Features - The Simplera Sync™ sensor is designed to work seamlessly with the MiniMed™ 780G system, which can now utilize both the Guardian™ 4 sensor and the new Simplera Sync™ sensor [1][3] - The system allows for flexible glucose targets as low as 100 mg/dL and has shown real-world data indicating users achieve over 70% time in range when using optimal settings [2][6] - The MiniMed™ 780G system is the only one that can be paired with an infusion set lasting up to 7 days, significantly reducing the frequency of injections [2][6] Company Commitment - Medtronic is dedicated to innovating diabetes management technologies to improve the quality of life for individuals living with diabetes [3][4] - The company plans a limited launch of the Simplera Sync™ sensor in the U.S. in fall 2025, further expanding its CGM options [3][4] - Medtronic has a long history of pioneering diabetes technology and aims to continue leading in this field through advanced sensors and intelligent dosing systems [4][5]