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Home » MiniMed wins CE mark for next-gen insulin pump, ups revenue guidance

MiniMed wins CE mark for next-gen insulin pump, ups revenue guidance

September 1, 2026 By Chris Newmarker

MiniMed Flex insulin pump system
A product image of the Flex insulin pump with the Simplera Sync sensor. [Image courtesy of MiniMed]
MiniMed (Nasdaq: MMED) today reported Street-beating first-quarter revenue, upping its full-year sales guidance as it notched an early European regulatory win.

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.”

The news, along with a positive Q1 report, sent MMED shares up more than 11% to $22.56 apiece by midday trading today. The S&P 500 was down slightly.

Read the full story on Drug Delivery Business News. 

And find out more about MiniMed and other top diabetes tech companies in our free Diabetes Technology Innovations Special Report. 

Filed Under: Business/Financial News, Diabetes, MassDevice Earnings Roundup, Regulatory/Compliance, Wall Street Beat Tagged With: CE Mark, insulin pump, MiniMed

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About Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at [email protected].

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