Medtronic Wins FDA Approval for Integration of Abbott's Instinct Sensor with MiniMed 780G

Medtronic has received FDA clearance for its SmartGuard algorithm to integrate with Abbott's Instinct glucose sensor. The integration will be with Medtronic's MiniMed 780G insulin pump, allowing for automated glycemic control. This will enable patients with diabetes to better manage their blood sugar levels. The FDA clearance is a significant step forward in the development of advanced diabetes management technology.

Medtronic has received FDA clearance for its SmartGuard algorithm to integrate with Abbott's Instinct glucose sensor, marking a significant advancement in diabetes management technology. This integration will be with Medtronic's MiniMed 780G insulin pump, allowing for automated glycemic control. The FDA clearance is a pivotal step in the development of advanced diabetes management solutions.

The integration of the Instinct sensor with the MiniMed 780G system enables patients with type 1 diabetes to better manage their blood sugar levels. The Instinct sensor, designed exclusively by Abbott for MiniMed automated insulin delivery (AID) and Smart MDI systems, is the world's smallest, thinnest, and most discreet integrated continuous glucose monitor (iCGM) with a wear time of up to 15 days [1].

The MiniMed 780G system, which offers meal detection technology and automatic adjustments every five minutes, is now available for type 2 diabetes with the Guardian™ 4 sensor. It will also be available with the Simplera Sync™ sensor upon completion of pre-orders later this month. The system's approval for use in adults with insulin-requiring 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 [2].

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. The integration of the Instinct sensor with the MiniMed 780G system aims to reduce the mental load of daily management, making it easier for people to live with diabetes [1].

Clinical trials have demonstrated improvements in glycemic outcomes, quality of life, and reductions in diabetes distress for users of the MiniMed 780G system. In a recently published pivotal trial with the Guardian™ 4 sensor and Simplera Sync™ sensor, participants experienced a 0.7% reduction in HbA1c and an increase in Time in Range to 81% [2].

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 expected to enhance patient outcomes and reduce treatment burden.

References:
[1] https://www.ainvest.com/news/medtronic-receives-fda-clearance-minimed-780g-system-including-integration-abbott-instinct-sensor-type-1-diabetes-2509/
[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