FDA Just Approved Medtronic Simplera Sync™

Medtronic announced on April 18, 2025, the FDA approval of Simplera Sync™ sensor, a significant advancement in Continuous Glucose Monitoring (CGM) technology. Although the Medtronic Simplera sensor release date is not confirmed yet, the company says a limited launch shall take place by fall 2025. Simplera is the first CGM sensor by Medtronic with an integrated transmitter.

This new sensor provides individuals with diabetes a streamlined, easy-to-use option for real-time glucose monitoring. However, due to limited supply and high demand, Medtronic has decided to implement a waitlist for customers who wish to get the sensor as it becomes available starting in Fall 2025.

Key Features of Simplera Sync™:

• No Fingersticks Required: The sensor does not need calibration and provides real-time glucose readings without the need for additional blood tests.
• Integrated with MiniMed™ 780G: The sensor works seamlessly with the MiniMed™ 780G insulin pump, enabling automatic insulin delivery to help maintain glucose levels within a target range.
• User-Friendly App: The Simplera app for smartphones and tablets provides users with glucose readings and trends, as well as alerts for high and low glucose levels.

Medtronic is working to increase the supply of Simplera Sync™, but in the meantime, interested customers will be added to the waitlist to receive updates and priority once inventory is sufficient. The company has not yet launched a dedicated waitlist or pre-order system.

Additionally, Medtronic is also partnering with Abbott to deliver a smaller and longer-wear sensor, set to work exclusively with the MiniMed™ 780G system. This collaboration is in its early stages, with Medtronic’s submission for FDA clearance now underway. Customers who opt to wait for this next-generation CGM will be enrolled in Medtronic’s Innovations Program, giving them first access to the new device once it is approved.

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A Bit About Medtronic

With 78 manufacturing sites globally, Medtronic is a leading global medical technology company headquartered in Dublin, Ireland, with its operational headquarters in Minneapolis, Minnesota. Founded in 1949 by Earl Bakken and Palmer Hermundslie in a Minneapolis garage, the company began as a medical equipment repair shop. Medtronic’s legacy in medical device development began in 1957.

Some Medtronic CGM Sensors

Medtronic has a history of pioneering diabetes management technologies, including several Continuous Glucose Monitoring (CGM) systems in the U.S., each with specific sensor lifespans. Below is a detailed overview of the lifespan for each Medtronic CGM sensor currently available:

Medtronic CGM Systems & their Lifespans

Simplera Sync: A Leap Forward in CGM Technology

Requiring no fingerstick, Simplera Sync is disposable, providing real-time glucose readings and trends to help individuals make informed decisions about their diabetes management. The CGM device has been invented to be used with the MiniMed™ 780G insulin pump system.

Key Features:

• No Fingersticks Required: The system does not require calibration and is designed to replace fingerstick blood glucose testing for diabetes treatment decisions.
• Real-Time Glucose Monitoring: Provides continuous glucose readings to help users monitor their glucose levels throughout the day.
• Easy App: The smartphones and tablets compatible Simplera Sync app is expected to display glucose values & trends. It may also allow users to set alerts for high and low glucose levels.
• Integration with MiniMed™ 780G System: When used with the MiniMed™ 780G insulin pump, the Simplera Sync™ sensor enables automated insulin delivery to maintain glucose levels within a target range.

Comparison Table: Simplera Sync™ vs. Guardian™ Sensor 3

Conclusion:

Medtronic Simplera Sync has been approved by the FDA. This is the first all in one CGM system by Medtronic which is going to be AID compatible as well. Due to the limited supply and high demand, a waiting list may soon be publicly available.  However, for people looking to buy CGMs using their credit/debit cards or claim their CGM using insurance can check out their eligibility here.