Medtronic plc has submitted two 510(k) applications to the U.S. Food and Drug Administration (FDA) seeking clearance for an interoperable insulin pump system, a critical advancement in its strategic partnership with Abbott announced last year.
The submissions include an application for the MiniMed 780G pump as an alternate controller enabled (ACE) insulin pump and a separate application for its SmartGuard algorithm as an interoperable automated glycemic controller (iAGC). These clearances would enable Medtronic's technology to function within an automated insulin delivery system that incorporates components from different manufacturers.
"We understand how meaningful these advancements are, and we're working with urgency to bring enhanced CGM options to our customers," said Que Dallara, Executive Vice President and President of Medtronic Diabetes. "This collaboration with Abbott marks an important step forward in providing innovative solutions and more choice for our customers."
Strategic Partnership Details
The regulatory submissions follow the partnership announcement from August 2024, when Medtronic and Abbott agreed to collaborate on an integrated diabetes management system. Under the agreement, Abbott will supply Medtronic with a continuous glucose monitoring (CGM) sensor based on its most advanced CGM platform. The system, including the Abbott CGM, will be sold exclusively by Medtronic.
This partnership represents a significant shift in Medtronic's approach to diabetes technology. Historically, the company has focused on pairing only its own devices in closed-loop systems. Meanwhile, Abbott, which leads the CGM market, has established integration partnerships with multiple insulin pump manufacturers, including Insulet, Tandem Diabetes Care, and Beta Bionics.
Automated Insulin Delivery Systems
Automated insulin delivery systems, sometimes called "artificial pancreas" systems, combine insulin pumps with continuous glucose monitors and algorithms that automatically adjust insulin delivery based on real-time glucose readings. These systems aim to reduce the burden of diabetes management while improving glucose control.
The interoperability of components is increasingly important in the diabetes technology landscape, as it allows patients and healthcare providers to select the best combination of devices for individual needs. FDA clearance of Medtronic's submissions would expand options for people with diabetes who prefer to mix components from different manufacturers.
Market Implications
The diabetes technology market has been trending toward interoperability and patient choice. Medtronic's move aligns with this industry direction while leveraging Abbott's strong position in the CGM market. The partnership could potentially strengthen both companies' competitive positions against other players in the automated insulin delivery space.
For Medtronic, which has faced challenges in its diabetes business in recent years, the collaboration with Abbott represents an opportunity to enhance its product offerings and potentially regain market share. The company's diabetes division has been working to innovate and adapt to changing market dynamics.
Next Steps
Medtronic indicated that more details about the integrated system will be shared once FDA clearance is secured. The timeline for potential approval remains uncertain, as the regulatory review process typically takes several months.
The company's headquarters are in Galway, Ireland, and it employs approximately 95,000 people across more than 150 countries. Medtronic's diabetes business continues to focus on advancing technology to improve outcomes for people living with diabetes through sensors, intelligent dosing systems, and data science applications.
