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CE mark

MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target

MedDevice Startups Staff · Sep 1 · 2 min read · Via Drug Delivery Business

MiniMed said on September 1 that its Flex insulin pump system with the Simplera Sync sensor now has a CE mark, months ahead of the year end target the company had set. The European launch is planned for November. The FDA cleared the same system in March, and the US launch followed in the summer.

Revenue for the quarter ended July 31 came in at $843 million, up 17 percent. Earnings were breakeven against a consensus of 9 cents. MiniMed raised full year organic growth guidance to 10.5 percent from 10 percent and held its adjusted EBITDA margin outlook near 16 percent. Shares rose 11 percent to $22.56.

On the pipeline, the company said it filed the Flex patch pump with the FDA ahead of schedule, finished enrollment in the pivotal trial for its Vivera closed loop algorithm, and won an IDE for an extended wear sensor.

The sequence matters if you are building an automated insulin delivery system. FDA in March, CE mark in September, European launch in November.

Questions & Answers

What did MiniMed get a CE mark for in September 2026?

MiniMed received a CE mark for the MiniMed Flex insulin pump system used with the Simplera Sync sensor, announced on September 1, 2026, with a European launch planned for November 2026.

When was the MiniMed Flex insulin pump cleared by the FDA?

The FDA cleared the MiniMed Flex system in March 2026, and MiniMed launched it in the United States in the summer of 2026.

What were MiniMed's first quarter results?

MiniMed reported revenue of $843 million for the quarter ended July 31, 2026, up 17 percent year over year, and raised full year organic revenue growth guidance to 10.5 percent.

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