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Medtronic wins FDA nod for new Simplera Sync CGM with MiniMed 780G

April 21, 2025 By Sean Whooley

Medtronic Simplera Sync CGM with MiniMed 780G (1)
The MiniMed 780G automated insulin delivery system with the Simplera Sync CGM. [Image courtesy of Medtronic]
Medtronic (NYSE:MDT) announced that the FDA approved its Simplera Sync continuous glucose monitor for use with the MiniMed 780G.

Approval provides more options for users of the automated insulin delivery (AID) system, which can also work with the Guardian 4 sensor.

Simplera Sync, a disposable, all-in-one sensor requires no fingersticks or overtape. It works with SmartGuard technology and features a simple, two-step insertion process.

Medtronic initially won FDA approval in August for its next-generation Simplera CGM. The Simplera platform includes the Simplera CGM for use with the InPen smart insulin pen and Simplera Sync specifically for integration with the MiniMed 780G. The medtech giant picked up CE mark for Simplera Sync with MiniMed 780G in January 2024.

MiniMed 780G offers meal detection technology and provides automatic adjustments and corrections to sugar levels every five minutes. This occurs for both basal (background) and bolus (mealtime) insulin needs.

Medtronic plans to begin a limited Simplera Sync CGM rollout in the fall.

“We’re committed to driving innovation that makes life easier for those living with diabetes so they can forget about their diabetes as much as possible throughout the day,” said Que Dallara, EVP and president of Medtronic Diabetes. “Our MiniMed 780G system delivers advanced diabetes technology for so many around the world, and we’re excited to continue evolving this experience with expanded CGM options —including our Simplera Sync sensor, which we look forward to bringing to people living with diabetes in the U.S.”

Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Patient Monitoring, Regulatory/Compliance, Technology Tagged With: FDA, Medtronic

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

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