Medtronic receives key approvals for automated insulin pump
Medtronic has received an expanded European CE mark approval for its MiniMed 780G insulin pump system. The device is now approved to be used by individuals 2 years and older—including those who are pregnant—and it can be used by patients with type 2 diabetes.
“Advancements in Automated Insulin Delivery systems are revolutionizing how we care for children with type 1 diabetes,” Dr. Fiona Campbell, a well-known pediatric endocrinologist in the U.K. who chairs the National Children & Young People’s Diabetes Network, said in a statement. “For families, these systems lift the relentless burden of constant monitoring and insulin adjustments. Better glucose control in children can support healthier growth and brain development, better sleep, and the freedom to simply enjoy being a child. It's a transformative shift in both outcomes and quality of life.”
Officials reviewed recent data from the LENNY clinical trial when approving the MiniMed 780G for younger patients. That analysis, focused on children between the ages of 2 and 6 with type 1 diabetes, highlighted the safety and effectiveness of treating these young patients with the Medtronic technology. Another recent analysis highlighted the benefits of using the MiniMed 780G system in patients with type 2 diabetes.
Are expanded FDA approvals next?
According to Medtronic, the company is also working to secure expanded approvals for the MiniMed 780G system from the U.S. Food and Drug Administration (FDA). The FDA approved the device back in April 2023 for patients with type 1 diabetes seven years and older. Now, however, the agency is reviewing a submission to approve the technology for individuals with type 2 diabetes. Meanwhile, additional studies on younger patients are already underway.
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