Medtronic Announces FDA Approval of Simplera™ CGM and Global Partnership with Abbott

The Simplera™ continuous glucose monitor (CGM) was approved by the Food and Drug Administration (FDA) on August 7, 2024. According to a press release from Medtronic, Simplera™ is Medtronic’s first disposable, all-in-one CGM, and is changing the way people manage diabetes with its:

• Compact size
• Ease of use
• Elimination of the need for overtape.

Simplera™ CGM: A Game-Changer in Diabetes Management

The Simplera™ platform introduces a new era in CGM technology with its discreet and simplified design.

The platform includes two key components:

1. Simplera™ CGM: With the InPen™ connected (“smart”) insulin pen, this advanced CGM can be used to create a Smart MDI (multiple daily injections) system. It offers a streamlined insertion and wear experience, making diabetes management more convenient.
2. Simplera Sync™ Sensor: Designed for integration with the MiniMed™ 780G system, this sensor complements the existing high-satisfaction levels of the MiniMed™ 780G system, which has received positive feedback in Europe.

FDA Approval Open the Doors

This approval opens the door for the revised InPen™ smart-insulin-pen-app to be submitted in the future.

It also makes it easier for the InPen™ to integrate with the Simplera™ CGM as part of an all-inclusive Smart MDI system.

Strategic Global Partnership with Abbott

In an effort to further expand its CGM offerings, Medtronic has also announced a global partnership with Abbott.

Abbott will provide Medtronic with a CGM that is specifically made to function with Medtronic’s smart-dosing equipment and software for both Smart MDI and automated-insulin-delivery (AID) systems.

Under this partnership, Medtronic will exclusively sell systems incorporating the Abbott-based CGM.

“Our partnership with Abbott allows us to expand access to our advanced automated insulin delivery and Smart MDI systems that deliver best-in-class outcomes with the most widely used CGM in the world,” said Que Dallara, executive vice president and president of Medtronic Diabetes. “We look forward to offering our Simplera™ platform alongside this integrated CGM to bring more choice to people living with diabetes within one seamless Medtronic experience.”

Future Integration

Medtronic plans to initiate a limited-market release in the U.S., starting with existing standalone CGM and InPen™ customers.

Meanwhile, the Simplera Sync™ sensor is under separate regulatory review by the FDA and is currently investigational in the U.S.

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WRITTEN BY Daniel Trecroci, POSTED 08/09/24, UPDATED 08/10/24

Dan has written about diabetes for more than 20 years. He was one of Diabetes Health's first recruits, and throughout his 10 + years as Managing Editor he wrote/published thousands of articles and helped establish Diabetes Health as the premiere resource for people with diabetes. He later became the Content Manager for OneTouchGold—Johnson & Johnson/LifeScan’s official digital publication for its metering-technology customers. Under his leadership, OneTouchGold received the Web Marketing Association’s award for “Best Health & Wellness" web site. Dan has also written for the Diabetes Research Institute, dLife, diaTribe, Healthline, CareDx, Pendulum Therapeutics, and Hero Bread.