Medtronic Seeks FDA Clearance for Interoperable Insulin Pump, Advancing Abbott Collaboration

Medtronic, a leading medical device manufacturer, has taken a significant step forward in its partnership with Abbott by submitting two 510(k) applications to the U.S. Food and Drug Administration (FDA) for its latest insulin pump technology. This move marks a pivotal moment in the diabetes management landscape, potentially expanding options for patients and healthcare providers alike.

FDA Submissions for Interoperable Insulin Delivery System

Medtronic announced on Thursday that it has filed two separate 510(k) submissions with the FDA. The first application is for the MiniMed 780G insulin pump as an alternate controller enabled device (ACE). The second submission is for the SmartGuard insulin dosing algorithm as an interoperable automated glycemic controller (iAGC).

These submissions are crucial for Medtronic's strategy to create an interoperable automated insulin delivery (AID) system. If cleared, the technology would allow Medtronic's pumps and algorithms to work seamlessly with glucose monitoring devices from other manufacturers, a significant departure from the company's previous closed-system approach.

Implications of the Abbott-Medtronic Collaboration

The FDA submissions represent a tangible outcome of the collaboration between Medtronic and Abbott, two companies that have historically been rivals in the diabetes technology space. This partnership, announced last year, involves Abbott developing glucose sensors exclusively for use with Medtronic's insulin pumps and pens, while Medtronic will be responsible for selling the integrated continuous glucose monitoring (CGM) systems.

Que Dallara, president of Medtronic's diabetes business, emphasized the importance of this development, stating that it "marks an important step forward in providing innovative solutions and more choice for our customers."

Shifting Landscape in Diabetes Management Technology

This move by Medtronic reflects a broader trend in the diabetes management industry towards interoperability and patient choice. Abbott, which leads the CGM market, has already established integration partnerships with other insulin pump manufacturers such as Insulet, Tandem Diabetes Care, and Beta Bionics.

While pursuing interoperability with Abbott's sensors, Medtronic continues to develop its own CGM technology. The company recently received FDA approval for its Simplera Sync sensor to be used with the MiniMed 780G insulin pumps as part of an AID system, demonstrating its commitment to advancing both proprietary and collaborative solutions in diabetes care.