The Northridge, California–based diabetes tech company, spun out of Medtronic earlier this year, announced a CE mark for its next-gen, app-controlled MiniMed Flex insulin pump — well ahead of the company’s calendar 2026 year-end target. MiniMed officials expect a European commercial launch in November. The automated system already launched in the U.S. over the summer after FDA clearance in March.

“This is a proud moment for our team and an important step forward for people living with diabetes across Europe,” MiniMed CEO Que Dallara said in a news release. “We believe diabetes technology should deliver best-in-class clinical outcomes while being discreet enough to fade into everyday life. This milestone brings us closer to making that experience available to more people across Europe.”