Medtronic Takes Major Step Forward in Diabetes Technology with FDA Submission for Interoperable Insulin Pump

Medtronic Drives Forward with Interoperable Insulin Pump Submission to FDA

GALWAY, Ireland, April 24, 2025 — Medtronic plc, a prominent player in the healthcare technology sector, has announced a significant milestone in diabetes management by submitting 510(k) applications to the U.S. Food and Drug Administration (FDA). This submission is aimed at gaining clearance for an interoperable insulin pump, designed to integrate seamlessly with Abbott's cutting-edge continuous glucose monitoring (CGM) system.

This initiative not only reflects Medtronic’s commitment to innovation but also highlights a collaborative effort with Abbott, a leading name in glucose monitoring technology. The 510(k) application specifically involves Medtronic's MiniMed™ 780G pump, which would serve as an alternate controller enabled (ACE) pump, alongside a separate submission for its SmartGuard™ algorithm, which acts as an interoperable automated glycemic controller (iAGC).

Que Dallara, Executive Vice President and President of Medtronic Diabetes, expressed enthusiasm regarding these advancements, stating, "We understand how meaningful these advancements are, and we're working with urgency to bring enhanced CGM options to our customers." This statement encapsulates the urgency and importance that Medtronic places on enhancing its offerings to better serve diabetes patients.

The recent submission comes on the heels of an announcement made last August, where Medtronic and Abbott revealed their collaboration to create an integrated system. This system would allow Medtronic to offer a CGM that operates exclusively with their smart dosing devices and software, aimed at facilitating both automated insulin delivery and smart multiple daily injections.

With the addition of Abbott's CGM to their product lineup, these systems promise to deliver a more holistic approach to diabetes management. It's noteworthy that these solutions will be exclusively sold by Medtronic, ensuring that patients have access to the latest advancements in diabetes care.

As the healthcare landscape continues to evolve, technological advancements like these not only improve patient outcomes but also offer a glimpse into the future of diabetes management. The integration of process-driven technologies, such as AI and data science, is set to redefine patient care standards, empowering individuals living with diabetes to manage their condition more effectively.

Medtronic Diabetes is on a mission to alleviate the burden associated with diabetes by equipping individuals with advanced technology and unwavering support. For over four decades, Medtronic has been pioneering innovative solutions that enhance the quality of life for diabetes patients. Their commitment to future diabetes management includes the development of next-generation CGM sensors and intelligent dosing systems that leverage data for optimal performance.

Medtronic’s bold commitment to health technology innovation is reflected in their overarching mission: to alleviate pain, restore health, and extend life. With a diverse global team of over 95,000 professionals across 150 countries, Medtronic is focused on delivering breakthrough therapies that impact the lives of patients worldwide.

As they await FDA clearance for this exciting new pump, Medtronic looks forward to sharing further details about this project and its potential impact on diabetic care when approvals are secured. The collaborative efforts with Abbott signal a promising future for individuals affected by diabetes, highlighting Medtronic's role as a leader in transforming healthcare technology.

To learn more about Medtronic and the developments in diabetes technology, visit www.medtronic.com.