Medtronic has received FDA Breakthrough Device Designation for its next-generation closed-loop insulin delivery system, which combines an advanced CGM with an AI-driven pump requiring zero manual bolus input from the user.
Medtronic has announced that the FDA has granted Breakthrough Device Designation to its next-generation automated insulin delivery (AID) platform, internally codenamed Project Synergy, representing a significant advance over the current MiniMed 780G system.
The new system integrates Medtronic's Simplera Sync CGM with a fourth-generation control algorithm that eliminates the need for manual mealtime bolus dosing — a first for a commercial insulin pump system.
How It Works
Project Synergy uses a multimodal sensing approach that combines glucose data, accelerometer readings and meal detection signals to predict postprandial glucose excursions and automatically deliver pre-emptive insulin boluses.
- Zero meal announcement required
- Predicted time in range >85% in pivotal trial
- Compatible with Simplera Sync (7-day wear)
- Predictive low glucose management
- Remote monitoring via Medtronic app
Breakthrough Designation typically reduces FDA review time by 25-30%. Medtronic expects to file a PMA application by Q4 2026, with potential commercial launch in 2027.
