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.
For the quarter ended July 31, the company broke even on $843 million in revenue. Sales were up 17% year-over-year.
The earnings didn’t meet the Wall Street consensus of 9¢ EPS but beat revenue expectations of $828.43.
“MiniMed delivered an excellent start to our fiscal year, with accelerating U.S. growth, continued double-digit international growth, and strong execution across our innovation pipeline,” Dallara said. “The U.S. launch of MiniMed Flex is doing exactly what we designed it to do: bringing new patients into the MiniMed ecosystem, driving competitive conversions, and generating significant new account growth.”
MiniMed is now forecasting 10.5% full-year organic revenue growth, up from the previous guidance of 10.0%. The company reaffirmed an adjusted EBITDA margin of rougly 16% for the year.
Other news announced today included:
- MiniMed Fit patch pump submission to the U.S. FDA, ahead of fall target, with a full U.S. launch expected summer 2027;
- Completion of enrollment for the Vivera fully-closed loop algorithm U.S. pivotal trial for type 1 and type 2 diabetes, with the algorithm on track for a U.S. launch in the second half of calendar 2027;
- An FDA IDE for the next-gen MiniMed extended wear sensor, with first enrollment in the pivotal trial expected this fall.
Said Dallara: “As our ecosystem continues to come together, we are well positioned to accelerate growth, strengthen our leadership in automated insulin delivery, and create long-term shareholder value.”
