European regulatory bodies approve expansion of Medtronic's MiniMed 780G insulin pump system for Type 2 diabetes management
### Medtronic's MiniMed 780G System Expands Its Reach in Europe
In a significant development for the management of diabetes, Medtronic's MiniMed 780G system has received expanded CE Mark approval for use in individuals with type 2 diabetes in Europe. This marks a significant step forward in expanding the system's reach to a larger patient population.
#### Clinical Trial Results
The approval was supported by clinical trial data from 95 individuals with type 2 diabetes. The use of the MiniMed 780G system resulted in a 0.7% reduction in HbA1c levels and an increase in time in range to 80%. Moreover, the time spent below the target glucose range was under 0.5%.
Real-world data from 26,427 users identified as having type 2 diabetes showed good glycemic control. On average, users exceeded the international consensus of 70% time in range and maintained time below range at less than 1%.
#### FDA Review Status
The MiniMed 780G system is currently under review by the FDA for approval for use in individuals with type 2 diabetes in the United States. The system is already approved for type 1 diabetes patients aged seven and older.
#### Recent Developments
The system has been approved for expanded use in Europe for individuals two years and older, including those who are pregnant. Additionally, Medtronic is conducting trials to examine its use in younger patients with type 1 diabetes.
The MiniMed 780G system joins other automated insulin delivery systems like Insulet's Omnipod 5 and Tandem Diabetes Care's system, which have also received FDA clearance for both type 1 and type 2 diabetes.
In other news, Medtronic has announced plans to spin off its diabetes business into a separate, public company within the next 18 months. The timeline for this spin-off was not specified.
The growth in Medtronic's diabetes segment revenue has been attributed to the increase in the MiniMed 780G installed base in the U.S. and international markets. The diabetes segment revenue grew by nearly 12% year over year to $647 million.
The article does not provide any new information about the FDA review or CE mark expansion for the MiniMed 780G system in the U.S. or Europe. It also does not mention any new studies or trials related to the system.
The article was published on May 21, 2025, and was reported by Ricky Zipp.
- The MiniMed 780G system, a device designed for diabetes management, has received expanded CE Mark approval in Europe for use in individuals with type 2 diabetes.
- The approval was based on clinical trial data from 95 individuals with type 2 diabetes, showing a 0.7% reduction in HbA1c levels and an increase in time in range to 80%.
- Real-world data from 26,427 users revealed good glycemic control, with an average of 70% time in range and less than 1% time below range.
- The FDA is currently reviewing the MiniMed 780G system for approval for use in type 2 diabetes patients in the United States.
- The system is already approved for type 1 diabetes patients aged seven and older and for individuals two years and older in Europe, including pregnant women.
- Medtronic is also conducting trials to examine the system's use in younger patients with type 1 diabetes.
- In other medtech news, Medtronic plans to spin off its diabetes business into a separate, public company within the next 18 months, with no timeline specified. This spin-off is attributed to the growth in the diabetes segment revenue, which grew by nearly 12% year over year to $647 million.
