Medtronic, a global leader in healthcare technology, announced two significant U.S. Food and Drug Administration (FDA) regulatory milestones for its MiniMed 780G automated insulin delivery system.

The FDA has cleared the SmartGuard algorithm as an interoperable automated glycemic controller (iAGC), enabling integration with the Instinct sensor developed by Abbott for people with type 1 diabetes. The FDA also approved the MiniMed 780G system for use in adults (18+) with insulin-requiring type 2 diabetes, marking the first and only automated insulin delivery (AID) system with Meal Detection™ technology for this population.

“These milestones represent an important step forward in our mission to bring the proven performance of our MiniMed 780G system to more people living with diabetes,” said Que Dallara, Executive Vice President and President of Medtronic Diabetes and CEO Designate of MiniMed. “By integrating Abbott’s Instinct sensor and expanding access to those with type 2 diabetes, we’re advancing a smarter dosing ecosystem that offers more choice, flexibility, and simplicity—backed by the trusted support Medtronic customers rely on.”

The Instinct sensor, designed exclusively by Abbott for MiniMed automated insulin delivery and Smart MDI systems, is the world’s smallest and thinnest integrated continuous glucose monitor (iCGM). It offers up to 15 days of wear and delivers a discreet, user-friendly experience. Integration with the MiniMed 780G pump completes the FDA premarket approval pathway for people with type 1 diabetes. Ordering of the Instinct sensor will begin following final compliance documentation, with priority access for existing customers through the Medtronic Innovations Program. Pre-orders for the Simplera Sync sensor will also open later this month.

“Abbott’s biowearable technology has long set the standard for accuracy and accessibility in glucose monitoring,” said Chris Scoggins, Executive Vice President of Abbott’s Diabetes Care business. “Connecting it with the MiniMed 780G system reduces the mental load of daily diabetes management, helping people live healthier, easier lives.”

The MiniMed 780G system is already available for type 2 diabetes with the Guardian 4 sensor and will soon be available with the Simplera Sync sensor. Medtronic also plans to pursue additional 510(k) clearances for an interoperable pump indicated for type 2 diabetes, further expanding compatibility with Abbott’s Instinct sensor.