MiniMed Flex™ system is FDA cleared

Footnotes

† Refers to SmartGuard^™ technology. Individual results may vary.

Important Safety Information: MiniMed Flex™ system with SmartGuard™ technology with Simplera Sync™ sensor

The MiniMed Flex™ system is intended for the continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable rates for the management of type 1 diabetes mellitus in persons 7 years of age and older, and of type 2 diabetes mellitus in persons 18 years of age and older requiring insulin. The system is also intended to continuously monitor glucose values in the fluid under the skin. The MiniMed Flex™ system includes SmartGuard™ technology, which can be programmed to automatically adjust insulin delivery based on continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values.

The Simplera Sync™ sensor can be used one time and has a life up to 6 days, followed by a grace period of 24 hours. During the grace period, the sensor will continue to work as it did during the first 6 days, to allow the patient to change their sensor more flexibly. However, some sensors may not survive the full wear period for a variety of reasons. Please be prepared to replace the sensor during the grace period to ensure sensor glucose values continue to be monitored.

The Simplera Sync™ sensor is not intended to be used directly to make therapy adjustments while the MiniMed Flex™ system is operating in manual mode. All therapy adjustments in Manual mode should be based on measurements obtained using a blood glucose meter and not on values provided by the Simplera Sync™ sensor. The Simplera Sync™ sensor has been studied and is approved for use in patients ages 7 years and older and in the arm insertion site only. Do not use the Simplera Sync™ sensor in the abdomen or other body sites, including the buttocks, due to unknown or different performance that could result in hypoglycemia or hyperglycemia.

The Medtronic MiniMed Flex™ System consists of the following devices: MiniMed Flex™ Insulin Pump and the Simplera Sync™ sensor. The system requires a prescription from a healthcare professional.

WARNING: Do not use the MiniMed Flex™ system until appropriate training has been received from a healthcare professional. Training is essential to ensure the safe use of the MiniMed Flex™ system.

WARNING: Do not use SG values to make treatment decisions, including delivering a bolus, while the pump is in Manual Mode. When the SmartGuard™ feature is active and you are no longer in Manual Mode, the pump uses an SG value, when available, to calculate a bolus amount. However, if your symptoms do not match the SG value, use a blood glucose (BG) meter to confirm the SG value. Failure to confirm glucose levels when your symptoms do not match the SG value can result in the infusion of too much or too little insulin, which may cause hypoglycemia or hyperglycemia.

Pump therapy is not recommended for people whose vision or hearing does not allow for the recognition of pump signals, alerts, or alarms. The safety of the MiniMed Flex™ system has not been studied in pregnant women or in persons using other anti-hyperglycemic therapies that do not include insulin. For complete details of the system, including user guides and important safety information such as indications, contraindications, warnings and precautions associated with system and its components, see https://bit.ly/MiniMedRisks

Important Safety Information: MiniMed^™ 780G system with SmartGuard^™ technology with Instinct sensor, Simplera Sync^™ sensor, and Guardian^™ 4 sensor

The MiniMed^™ 780G system is intended for the continuous delivery of basal insulin at selectable rates and the administration of insulin boluses at selectable rates for the management of type 1 diabetes mellitus in persons 7 years of age and older, and of type 2 diabetes mellitus in persons 18 years of age and older requiring insulin. The system is also intended to continuously monitor glucose values in the fluid under the skin.

The MiniMed^™ 780G System includes SmartGuard^™ technology, which can be programmed to automatically adjust insulin delivery based on the continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the sensor glucose (SG) value falls below or is predicted to fall below predefined threshold values. The system is intended for use with connected sensors, including the Simplera Sync^™ and Guardian^™ 4 sensors and integrated continuous glucose monitors, including the Instinct sensor, each of which has different wear-time, form factor, insertion site, and other distinguishing characteristics that relate to sensor performance. Consult the appropriate sensor user guide when using the system. Discuss treatment decisions with your HCP.

WARNING: Do not use the MiniMed^™ 780G system until appropriate training has been received from a healthcare professional. Training is essential to ensure the safe use of the MiniMed^™ 780G system.

WARNING: Do not use SG values to make treatment decisions, including delivering a bolus, while the pump is in Manual Mode. When the SmartGuard^™ feature is active and you are no longer in Manual Mode, the pump uses an SG value, when available, to calculate a bolus amount. However, if your symptoms do not match the SG value, use a blood glucose (BG) meter to confirm the SG value. Failure to confirm glucose levels when your symptoms do not match the SG value can result in the infusion of too much or too little insulin, which may cause hypoglycemia or hyperglycemia.

Pump therapy is not recommended for people whose vision or hearing does not allow for the recognition of pump signals, alerts, or alarms. The safety of the MiniMed^™ 780G system has not been studied in pregnant women or in persons using other anti-hyperglycemic therapies that do not include insulin. For complete details of the system, including accessories and additional important safety information concerning indications, contraindications, warnings and precautions associated with the system and its components, please consult https://www.minimed.com/en-us/important-safety-information/ and the appropriate user guides at https://www.minimed.com/en-us/support/download-library/

©2026 Medtronic. MiniMed and MiniMed logo are trademarks of Medtronic MiniMed, Inc. The sensor shape and appearance, Abbott, and "a" logo are marks and/or designs of the Abbott group of companies in various territories and used under license. Sensor image ©2026 Abbott. ^™*Third–party brands are trademarks of their respective owners.

DreaMed Diabetes is a trademark of DreaMed Diabetes, Ltd. The MiniMed^™ 780G system algorithm includes technology developed by DreaMed Diabetes.

Important Safety Information: InPen™

The InPen system consists of a reusable insulin pen and mobile app and is for people living with diabetes. It can be used to deliver insulin, help calculate insulin doses, and estimate carbohydrates for meals. Those under the age of 7 should only use the device with an adult's supervision. A healthcare provider must prescribe InPen, provide dosage settings, and discuss all potential benefits and risks. Using the device with incorrect therapy settings may lead to severe highs and lows. The system should not be used by those unable to test blood glucose levels or the visually impaired. For additional product and important safety information, see https://bit.ly/MiniMedRisks

Important Safety Information: Simplera™ system

The Simplera™ system requires a prescription. It consists of a sensor and mobile app that perform real-time continuous glucose monitoring (CGM) for the management of diabetes in adults ages 18 years and older. The sensor is indicated for up to 6 days of use, plus an additional grace period of 24 hours. It is intended for use in home environments. The Simplera™ system does not require calibration. Blood glucose (BG) readings are required (1) during the first 12 hours of use, (2) if no sensor data is available, (3) when symptoms do not match the sensor glucose (SG) value, and (4) when taking certain medications. Not taking BG readings as indicated can lead to incorrect SG readings, over-administration of insulin, and possible hypoglycemia.

The Simplera™ app in combination with the Simplera™ sensor is intended for use only by patients and caregivers using a compatible mobile device and operating system, and who have sufficient experience to adjust mobile device audio and notification settings. When taking any of the following medications, consult a healthcare professional prior to using the system, as these can bias SG readings, potentially leading to the over-administration of insulin and a higher risk of hypoglycemia: acetaminophen, paracetamol, hydroxyurea, hydroxycarbamide. Sensor use can also result in skin irritation, bruising, discomfort, redness, bleeding, and infection, and sensors in general also pose a choking risk to young children. For complete details, consult the user guides and important safety information.