Medtronic Earns CE Mark for Expanded Use of MiniMed™ 780G Insulin Pump System

Approval now includes children as young as two, pregnant individuals, and people with type 2 diabetes across Europe

Medtronic’s CE Mark expansion for its MiniMed™ 780G system marks a major advancement in the delivery of diabetes care across Europe. By extending its use to children as young as two, pregnant individuals, and people with type 2 diabetes requiring insulin, the system demonstrates a new level of inclusivity and clinical versatility. These expanded indications are backed by strong clinical data and reflect the growing consensus that Automated Insulin Delivery (AID) systems are vital tools in optimizing glycemic control, reducing hypoglycemia, and improving quality of life—especially for high-need and vulnerable populations. This milestone underscores Medtronic’s commitment to expanding access to life-enhancing diabetes technologies across every stage of life.

The MiniMed™ 780G system offers automated, real-time insulin delivery adjustments based on continuous glucose monitoring data, allowing for tighter glucose control with less burden on patients and caregivers. In children aged 2–6, clinical trials have shown significant improvements in HbA1c and time in range, while easing parental concerns around nocturnal hypoglycemia. For pregnant individuals, where blood glucose targets are even more stringent, the system has shown effectiveness in achieving Pregnancy Time in Range (TIRp), reducing fluctuations, and enhancing overall maternal and fetal health. Similarly, people with insulin-requiring type 2 diabetes have benefited from meaningful HbA1c reductions and increased time in range, as shown in both clinical and real-world studies.

Looking ahead, this expanded European approval opens the door for broader global adoption of AID technology, potentially transforming the standard of care for millions living with diabetes. With regulatory reviews and clinical trials underway in the U.S., including efforts to bring the MiniMed™ 780G system to young children and those with type 2 diabetes, Medtronic continues to push forward on its mission to make advanced diabetes management accessible and personalized. As evidence continues to grow in favor of AID systems, the MiniMed™ 780G is well-positioned to lead the future of automated insulin therapy—empowering users with greater freedom, better outcomes, and improved everyday well-being.


MedTech Spectrum's Summary 
 
Broader Access Across Life Stages: Medtronic’s MiniMed™ 780G system has received CE Mark for expanded use in children as young as two, during pregnancy, and for people with type 2 diabetes—enabling more personalized and automated diabetes care for diverse, high-need populations.
 
Clinically Proven Benefits: Backed by data from multiple trials, the system delivers significant improvements in glycemic control, reduces hypoglycemia risk, and enhances quality of life through real-time, automated insulin adjustments tailored to individual needs.
 
Pathway to Global Expansion: With regulatory reviews ongoing in the U.S. and strong clinical momentum, the MiniMed™ 780G system is poised to become a global standard in automated insulin delivery—redefining diabetes management across age groups and disease types.