- Medtronic (MDT, Financial) submits 510(k) applications to FDA for new interoperable insulin pump.
- The pump will integrate with Abbott's advanced CGM platform.
- Exclusive distribution rights for the integrated system mark strategic partnership with Abbott.
Medtronic plc (MDT), a global leader in healthcare technology, has officially submitted 510(k) applications to the U.S. Food and Drug Administration (FDA) for clearance of an innovative interoperable insulin pump system. This development marks a significant milestone in Medtronic's strategic partnership with Abbott, aimed at expanding options for diabetes management.
The submission covers two critical components: the MiniMed™ 780G pump, identified as an alternate controller enabled (ACE) insulin pump, and the SmartGuard™ algorithm, serving as an interoperable automated glycemic controller (iAGC). These integrative technologies are designed to work in conjunction with Abbott's state-of-the-art continuous glucose monitoring (CGM) platform, offering potentially transformative benefits for diabetes patients.
Following the collaboration announcement in August 2024, this FDA submission represents a tangible step forward in enhancing Medtronic's product offerings. The partnership ensures that Abbott's CGM technology will work exclusively with Medtronic's dosing devices and software, providing a more cohesive and effective diabetes management solution. Importantly, these integrated systems will be marketed solely through Medtronic's distribution channels, fortifying its competitive position in the rapidly evolving diabetes technology market.
Que Dallara, EVP & President of Medtronic Diabetes, stated, "We understand how meaningful these advancements are, and we're working with urgency to bring enhanced CGM options to our customers." The company will disclose additional details upon securing FDA clearance, which would significantly expand Medtronic's diabetes technology portfolio, potentially influencing the $25+ billion diabetes technology market positively.
