FDA Clears MiniMed Flex

Looking for a more discreet insulin pump for summer? You’re in luck: earlier this week, the Food and Drug Administration (FDA) approved the MiniMed Flex, the company’s smallest and first smartphone app-controlled insulin pump. This marks MiniMed’s first FDA-approval as a standalone company from Medtronic. 

The MiniMed Flex is about half the size of the MiniMed 780G insulin pump and is designed to fit seamlessly into the lives of people living with diabetes, with insulin dosing available directly from your smartphone. The MiniMed Flex system is approved for people 7 years and older with type 1 diabetes, and for people 18 years and older with insulin-dependent type 2 diabetes. 

“At MiniMed, our mission is to make every day a better day for people with diabetes,” said Que Dallara, chief executive officer of MiniMed. “MiniMed Flex embodies that promise. It’s designed to work quietly and reliably in the background, with advanced automation wrapped in a compact, smartphone‑controlled pump. The result is technology that lets people spend less time managing diabetes and more time living their lives.”

The MiniMed Flex uses the SmartGuard algorithm with Meal Detection technology, which helps people manage blood sugar levels before, during and after they eat. The product can use either the Simplera Sync continuous glucose monitor (CGM) or the Instinct CGM, made by Abbott, for more flexibility for patients. 

Some new features of the MiniMed Flex include:

• Small design with high insulin capacity: the 300-unit insulin reservoir’s sleek design is great if you want an insulin pump that’s out of sight but still supports a variety of insulin needs
• Smartphone-controlled: the insulin pump is managed through a mobile app, which eliminates the traditional pump screen. Software updates are delivered right to your iOS or Android device
• Flexible CGM sensor compatibility: the MiniMed Flex can utilize the Simplera Sync CGM or the Instinct sensor for more user flexibility and choice
• Extended infusion set capabilities: the new system works with MiniMed’s infusion set portfolio, including the Extended infusion set, which allows up to 7 days of wear
• Automated insulin delivery performance, with patients achieving 80% time in range (TiR) with recommended settings

“MiniMed Flex represents an important leap forward for MiniMed,” said Anders Carlson, MD, medical director of the International Diabetes Center at Park Nicollet, director of the HealthPartners Diabetes Program, and an assistant professor in the University of Minnesota Medical School. “For many people living with diabetes, the burden of daily management can be overwhelming. By combining a discreet, screenless form factor with a powerful adaptive algorithm that responds quickly to changes in glucose, MiniMed Flex brings meaningful innovation exactly where it’s needed: into the flow of everyday life.”

MiniMed has also launched the MiniMed Forward Program, which helps customers upgrade from the MiniMed 780G insulin pump to MiniMed Flex for no added fee. If you’re already in-warranty on a MiniMed pump, you’ll be notified when the MiniMed Flex becomes commercially available in the United States with options on how to upgrade. 

The launch of the MiniMed Flex system will kick off with select MiniMed patients in spring 2026, followed by a broad, commercial launch this summer.