SHERIDAN, WYOMING – May 5, 2025 – Medtronic plc (NYSE: MDT), a global leader in healthcare technology, has officially submitted 510(k) applications to the U.S. Food and Drug Administration (FDA) for its MiniMed™ 780G pump and SmartGuard™ algorithm, paving the way for seamless integration with Abbott’s advanced continuous glucose monitoring (CGM) platform. This critical regulatory milestone strengthens Medtronic’s strategic partnership with Abbott and positions the company to deliver more interoperable, intelligent diabetes care solutions to the U.S. market.
Accelerating Innovation Through Strategic Interoperability
The FDA submissions include two distinct components: the MiniMed™ 780G pump as an Alternate Controller Enabled (ACE) insulin pump, and the SmartGuard™ algorithm as an Interoperable Automated Glycemic Controller (iAGC). This dual-filing approach reflects Medtronic’s long-term vision to expand interoperability within diabetes care, leveraging Abbott’s cutting-edge CGM platform to create more flexible, data-driven therapy options.
"We understand how meaningful these advancements are, and we're working with urgency to bring enhanced CGM options to our customers," said Que Dallara, EVP & president of Medtronic Diabetes. "This collaboration with Abbott marks an important step forward in providing innovative solutions and more choice for our customers."
This development builds on the companies’ August 2024 announcement of a collaboration to deliver a fully integrated diabetes management system. Under the terms of the agreement, Abbott will supply Medtronic with CGM sensors that are designed exclusively for use with Medtronic’s smart dosing technologies—spanning both automated insulin delivery and smart multiple daily injection (MDI) systems. Medtronic will be the exclusive distributor of the integrated system, reinforcing its commitment to offering a streamlined, patient-focused ecosystem.
Driving Strategic Value in a Competitive Market
The diabetes care market is rapidly evolving, with increasing demand for systems that allow for greater personalization, interoperability, and intelligent automation. Medtronic’s pursuit of FDA clearance for the MiniMed™ 780G and SmartGuard™ algorithm not only supports this demand but also:
- Strengthens Medtronic’s portfolio of connected insulin delivery solutions
- Broadens access to CGM-integrated therapies for patients and providers
- Positions Medtronic to capture greater share in the insulin pump and smart injection segments
- Leverages Abbott’s proven CGM technology for enhanced real-time glucose visibility
By offering a modular system built on FDA-recognized interoperability standards (ACE and iAGC), Medtronic is setting a new benchmark for agility and innovation in diabetes management.
Enhancing Outcomes Through Advanced Technologies
Medtronic Diabetes continues to lead with a patient-first philosophy, supported by over four decades of diabetes innovation. The company is focused on creating holistic diabetes care solutions that combine:
- Continuous glucose monitoring (CGM)
- Intelligent dosing algorithms
- Predictive analytics and AI-driven insights
- 24/7 support for improved user experience
These technologies are designed to empower individuals to better manage their diabetes, reduce manual burden, and improve time-in-range outcomes.
Looking Ahead
While FDA clearance is still pending, this submission signals Medtronic’s readiness to operationalize its strategic alliance with Abbott and redefine standards in CGM-integrated care. More information will be released once regulatory clearance is secured.
To learn more about Medtronic’s diabetes portfolio, visit www.medtronicdiabetes.com.