Medtronic secures FDA approval for Simplera CGM, announces global partnership with Abbott

IRELAND—Ireland-based Medtronic plc, a global leader in healthcare technology, has received approval from the U.S. Food and Drug Administration (FDA) for its Simplera™ continuous glucose monitor (CGM).

This approval marks a significant milestone for the company as it introduces its first disposable, all-in-one CGM, which is half the size of previous Medtronic CGMs.

The new design prioritizes discretion and ease of use, eliminating the need for overtape and simplifying users’ insertion and wear experience.

The Simplera platform introduces Medtronic’s latest CGM form factor, which includes the Simplera CGM itself.

This device is designed to function as part of a Smart Multiple-Daily Injection (MDI) system, in conjunction with the InPen smart insulin pen and the Simplera Sync sensor.

The Simplera Sync sensor is also intended to integrate with the MiniMed 780G system. This feature has already been met with positive reception in Europe following the CE marking and subsequent launch earlier this year.

Users have particularly praised the ease of use and insertion, further boosting satisfaction with the existing MiniMed 780G system.

The recent FDA approval for the Simplera™ CGM sets the stage for Medtronic’s upcoming submission for the updated InPen smart insulin pen app.

Once this app gains FDA clearance, it will enable seamless integration with the Simplera CGM as part of the Smart MDI system.

Medtronic plans to initiate a limited market release in the U.S., targeting current standalone CGM and InPen customers as the initial users.

Meanwhile, the Simplera Sync sensor is under separate review by the FDA and remains investigational in the U.S., with no current approval for commercial use.

In the meantime, Medtronic is also pursuing additional global regulatory submissions and approvals for both the Simplera CGM and the Simplera Sync sensor

Medtronic partners with Abbott for diabetes care

In a related development, Medtronic has announced a strategic global partnership with Abbott to expand CGM options for people living with diabetes.

Under this unique agreement, the two companies will collaborate on developing an integrated CGM based on Abbott’s most advanced CGM platform.

Abbott will supply Medtronic with a CGM that will work exclusively with Medtronic’s smart dosing devices and software, supporting both automated insulin delivery and Smart MDI systems.

These systems, including the Abbott-based CGM, will be sold exclusively by Medtronic.

The company expects this original equipment manufacturer (OEM) agreement to contribute positively to Diabetes revenue while being neutral to Diabetes gross margin.

However, the financial details of the partnership and the timing for commercial availability have not yet been disclosed.

Commenting on the partnership, Que Dallara, executive vice president and president of Medtronic Diabetes, emphasized that this collaboration with Abbott will expand access to their advanced automated insulin delivery and Smart MDI systems, which deliver best-in-class outcomes with the most widely used CGM in the world.

Dallara expressed enthusiasm about offering the Simplera™ platform alongside the integrated CGM, aiming to provide more options for people living with diabetes within a seamless Medtronic experience.

For his part, Jared Watkin, executive vice president of Abbott’s diabetes care business, echoed this sentiment and noted that the partnership brings together two global leaders in glucose sensing technology and insulin delivery.

He added that Abbott’s CGM technology has set the standard for accuracy, accessibility, and ease of use in continuous glucose monitoring.

The partnership aims to simplify diabetes management by connecting this CGM with Medtronic’s advanced insulin delivery systems and algorithms. This will allow people to spend less time focusing on their condition and more time living their lives.