Medtronic is seeking Food and Drug Administration clearance for an interoperable version of its latest insulin pump, an important step in the manufacturer’s collaboration with diabetes technology rival Abbott.
Medtronic said on Thursday that it made two 510(k) submissions to the FDA: one for its MiniMed 780G insulin pump as an alternate controller enabled device, and another for its SmartGuard insulin dosing algorithm as an interoperable automated glycemic controller.
The clearances would allow Medtronic’s technology to be part of an automated insulin delivery system, which can adjust insulin dosing to patients based on real-time readings from glucose monitors, using components made by other companies.
Medtronic makes insulin pumps and continuous glucose monitors, and in the past has sought to pair only its own devices. Meanwhile, Abbott, which leads the market for CGMs, has struck integration partnerships with pump makers including Insulet, Tandem Diabetes Care and Beta Bionics.
Que Dallara, president of Medtronic's diabetes business, said in a statement that the Abbott collaboration “marks an important step forward in providing innovative solutions and more choice for our customers."
Last year, the two companies formed an agreement for Abbott to exclusively make glucose sensors that work with Medtronic’s insulin pumps and pens, and Medtronic would sell the CGMs. The companies did not disclose the terms of the partnership.
Medtronic is still working on its own CGMs. The company recently received FDA approval to use its latest Simplera Sync sensor with its MiniMed 780G insulin pumps as part of an AID system.