Medtronic receives FDA approval for iAGC

By HME News Staff
Updated 12:47 PM CDT, Wed September 3, 2025
GALWAY, Ireland – Medtronic has received clearance for its SmartGuard algorithm as an interoperable automated glycemic controller (iAGC), enabling integration with Abbott’s Instinct sensor for Type 1 diabetes. The company has also received approval of the MiniMed 780G system for use in adults 18+ with insulin-requiring Type 2 diabetes. "These milestones mark an important next step in our work to bring the proven performance and outcomes of our MiniMed 780G automated insulin delivery system to more people living with diabetes,” said Que Dallara, EVP and president of Medtronic and CEO designate of MiniMed. “By enabling integration with the Instinct sensor and expanding the MiniMed 780G system to people with type 2 diabetes, we are advancing a smart dosing ecosystem designed to provide greater choice and flexibility, along with a more seamless experience. We're excited to expand our ecosystem of solutions under one roof with service our customers can count on around the clock." In the coming weeks, Medtronic and Abbott plan to complete their required compliance documentation, paving the way for sensor integration and marketing. Once that process is complete, ordering for the Instinct sensor with the MiniMed 780G system will begin. Existing customers will have priority access through the Innovations Program. Pre-orders for Simplera Sync sensor will also begin later this month. "We're working together to do what's best for people living with diabetes," said Chris Scoggins, EVP of Abbott's diabetes care business. "Abbott's biowearable technology has long set the standard for accurate, accessible, easy-to-use continuous glucose monitoring. Connecting it with the MiniMed 780G system aims to reduce the mental load of daily management, making it easier for people to live with diabetes."
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