Medtronic Receives FDA Clearance for MiniMed 780G System, Including Integration with Abbott's Instinct Sensor for Type 1 Diabetes.

Medtronic has received FDA clearance for its MiniMed 780G system, enabling integration with Abbott's Instinct sensor for type 1 diabetes. The clearance completes Medtronic's FDA pre-market approval pathway for the Instinct sensor integration with the MiniMed 780G system. The company and Abbott plan to finalize regulatory compliance documentation, after which ordering for the Instinct sensor with the MiniMed 780G system will begin.

Medtronic (NYSE: MDT) has received significant FDA regulatory milestones for its MiniMed 780G automated insulin delivery system. The FDA granted clearance for the SmartGuard algorithm as an interoperable automated glycemic controller (iAGC), enabling integration with Abbott's Instinct sensor. This integration is designed specifically for type 1 diabetes, marking a significant advancement in diabetes technology.

Additionally, the FDA approved the MiniMed 780G system for use in adults with insulin-requiring type 2 diabetes. This approval makes the MiniMed 780G the latest automated insulin delivery system available to this broader patient population, further expanding its addressable market.

These milestones are part of Medtronic's broader strategy to separate its Diabetes business into a standalone, publicly traded company within the next 15 months. The MiniMed 780G system, which offers meal detection technology and automatic adjustments every five minutes, is expected to enhance patient outcomes and reduce treatment burden.

Medtronic and Abbott plan to complete their regulatory compliance documentation, which will allow for the commencement of ordering the Instinct sensor with the MiniMed 780G system. Existing customers will have priority access through the Innovations Program, with pre-orders for the Simplera Sync™ sensor also set to begin later this month.

The approval of the MiniMed 780G system for type 2 diabetes aligns with the ADA Standards of Care, which now formally endorse automated insulin delivery systems for individuals with type 2 diabetes on intensive insulin therapy. Clinical trials have demonstrated improvements in glycemic outcomes, quality of life, and reductions in diabetes distress for users of the MiniMed 780G system.

Medtronic's Diabetes business is one of the largest diabetes tech companies globally. The company's mission is to make diabetes more predictable, embracing advanced diabetes technology and always-on support. The MiniMed 780G system is currently available for type 2 diabetes with the Guardian™ 4 sensor and will be available with the Simplera Sync™ sensor upon the completion of pre-orders.

References:
[1] https://www.massdevice.com/medtronic-fda-nods-pump-abbott-type2/
[2] https://news.medtronic.com/2025-09-02-FDA-Clears-MiniMed-TM-780G-System-to-Enable-Integration-with-the-Instinct-Sensor,-Made-by-Abbott,-and-Approves-Use-in-Type-2-Diabetes