Medtronic today announced two FDA regulatory milestones that broaden the MiniMed 780G system portfolio: clearance of the SmartGuard algorithm as an interoperable automated glycemic controller (iAGC), enabling integration with the Instinct sensor, made by Abbott, for type 1 diabetes, and approval of the MiniMed 780G system for use in adults 18+ with insulin-requiring type 2 diabetes.
This clearance, alongside the previously cleared MiniMed 780G insulin pump as an alternate controller enabled (ACE) pump, completes the Medtronic FDA pre-market approval pathway for the Instinct sensor integration with our MiniMed 780G system for people living with type 1 diabetes. The Instinct sensor, designed exclusively by Abbott for MiniMed automated insulin delivery (AID) and Smart MDI systems, offers a wear time of up to 15 days.
In the coming weeks, Medtronic and Abbott plan to complete their required compliance documentation enabling sensor integration and marketing. Completion of this step will promptly finalize the regulatory process, after which 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.
Separately, the FDA approved the MiniMed 780G system for people with insulin-requiring type 2 diabetes.
The MiniMed 780G system is currently available for type 2 diabetes with the Guardian 4 sensor and will be available with Simplera Sync sensor when pre-orders begin later this month. Medtronic also plans to submit 510(k) applications seeking clearance for an interoperable pump indicated for type 2 diabetes, which would enable future integration with the Instinct sensor.
