Medtronic Receives FDA Approval for Simplera™ CGM and Announces Strategic Partnership with Abbott in Diabetes Care

Recently, Medtronic (NYSE: MDT), a global leader in healthcare technology, announced that its Simplera™ Continuous Glucose Monitor (CGM) has received approval from the U.S. Food and Drug Administration (FDA). This is the company's first disposable all-in-one CGM, which is half the size of previous Medtronic CGMs. The discreet design simplifies the insertion and wearing experience, eliminating the need for a holster.

The Simplera™ platform adopts the company's latest CGM form factor, including the Simplera™ CGM, designed to function as part of the Smart MDI system, equipped with the InPen™ smart insulin pen and the Simplera Sync™ sensor, which is intended for integration with the MiniMed™ 780G system.

Simplera™ CGM and Simplera Sync™ sensors received the CE mark in Europe and were launched earlier this year, receiving positive feedback on ease of use and insertion, further enhancing the existing high satisfaction with the MiniMed™ 780G system.

The U.S. Food and Drug Administration (FDA) recently approved Simplera™ CGM, paving the way for the future submission of an updated InPen™ smart insulin pen application, which will facilitate integration with Simplera™ CGM as part of the Smart MDI system. Once FDA approval is obtained, Medtronic will initiate a limited market release in the United States, starting with existing standalone CGM and InPen™ customers. The FDA is also reviewing Simplera Sync™ sensor under a separate regulatory filing. It remains in the research phase in the U.S. and is not yet approved for commercial use.

Other global regulatory submissions and approvals for the Simplera™ CGM and Simplera Sync™ sensors are pending.

In addition, Medtronic announced a global partnership with Abbott to expand CGM options for people with diabetes. Under this unique agreement, the two companies will collaborate to develop integrated CGM systems based on Abbott's most advanced CGM platform. Abbott will supply Medtronic with CGMs that are specifically designed to work with Medtronic’s smart delivery devices and software, including automated insulin delivery and smart MDI systems. These systems, incorporating Abbott’s CGM, will be exclusively sold by Medtronic. Medtronic expects this Original Equipment Manufacturer (OEM) agreement to increase diabetes revenue while being neutral to diabetes gross margins. Other financial terms of the partnership and the timing of commercial availability have not been disclosed.

Medtronic Diabetes Executive Vice President and President Que Dallara said, "Our collaboration with Abbott allows us to expand access to advanced automated insulin delivery and smart MDI systems, which deliver top-tier outcomes powered by the world's most widely used CGM. We look forward to offering our Simplera™ platform with this integrated CGM, providing more choices for people with diabetes within a seamless Medtronic experience."

Medtronic continues to advance its product line for people requiring intensive insulin delivery, including next-generation durable and patch-based automated insulin delivery systems, smart pens, CGM, algorithms, software, and services, and will continue to expand treatment indications.

Jared Watkin, Executive Vice President of Abbott's Diabetes Care business, stated: "This collaboration pairs two global leaders in glucose sensing technology and insulin delivery." Abbott's CGM technology sets the standard for accurate, accessible, easy-to-use, and reliable continuous glucose monitoring. Connecting this CGM, built for Medtronic's advanced insulin delivery systems and algorithms, makes it easier for people to spend less time thinking about their diabetes and more time living their lives.

About Medtronic's Diabetes Business (www.medtronicdiabetes.com）

Medtronic Diabetes' mission is to alleviate the burden of diabetes by empowering individuals to live life on their own terms, equipped with the most advanced diabetes technology and always-on support. For over 40 years, we have pioneered groundbreaking innovations and are committed to shaping the future of diabetes management through next-generation sensors (CGM), intelligent drug delivery systems, and the power of data science and AI, all while consistently prioritizing customer experience.

About Medtronic

Medtronic, headquartered in Dublin, Ireland, is a global leader in healthcare technology, boldly addressing some of the most challenging health issues facing humanity by seeking and finding solutions.

This Issue's Planning: Shen Li

Editorial Responsibility: Chen Baolin

Author of this article: Yun Ye Xuan

Post-production:Ling Wujuan