FDA Clears MiniMed Flex, A Smaller and Smartphone-Controlled Insulin Pump

The US Food and Drug Administration has cleared MiniMed’s MiniMed Flex™, a next-generation discreet, smartphone-controlled insulin pump designed to fit seamlessly into everyday life.

As described in a March 18, 2026, release from the Company, the MiniMed Flex is about half the size of the MiniMed™ 780G pump and roughly the size of 2 stacked insulin vials. It is cleared for individuals ≥ 7 years of age with type 1 diabetes and for individuals ≥ 18 years of age with insulin-requiring type 2 diabetes. MiniMed Flex is the company's first screenless design created in partnership with people living with diabetes to deliver an intuitive, lifestyle‑friendly way to manage the condition.

"MiniMed Flex™ represents an important leap forward for MiniMed," 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, said in a statement. "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. This level of automation, paired with the freedom of smartphone control, has the potential to improve consistency, confidence, and ultimately clinical outcomes for a broad range of patients with diabetes."

In January 2026, the FDA granted 510(k) clearance to Medtronic’s MiniMed Go Smart Multiple Daily Injection (MDI) app for use by patients with type 1 diabetes or type 2 diabetes aged ≥7 years, as well as for children between 2-6 years under adult supervision.

The new MiniMed Flex™ is powered by MiniMed’s most advanced SmartGuard™ algorithm with Meal Detection™ technology, which has proven clinical performance that exceeds worldwide Time in Range recommendations. At commercial launch, MiniMed Flex™ will support the company's newest sensor portfolio, including Simplera Sync™ sensor and the Instinct sensor, made by Abbott.

Key product features include the small, sleek design with high insulin capacity, delivering a 300-unit insulin reservoir to support a range of insulin needs; the ability to manage the product through a compatible mobile app; sensor compatibility with the Company's newest sensor portfolio, including Simplera Sync™ sensor and the Instinct sensor, made by Abbott; extended infusion set options; and proven AID performance, with real-world results demonstrating 80% Time in Range with recommended settings.

MiniMed additionally announced the MiniMed™ Forward Program, which allows customers who start on the MiniMed™ 780G system to upgrade to the MiniMed Flex™ system at no cost.

"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 — 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. Securing FDA clearance for our first product as a standalone, public company — just one week after our IPO — marks a major milestone and underscores our commitment to delivering the breakthrough innovation our customers deserve."

References

1. MiniMed. MiniMed Announces FDA Clearance of MiniMed Flex™, the Company's Smallest Insulin Pump Featuring Its First Smartphone-Controlled Design. March 18, 2026. Accessed March 16, 2026. https://www.prnewswire.com/news-releases/minimed-announces-fda-clearance-of-minimed-flex-the-companys-smallest-insulin-pump-featuring-its-first-smartphone-controlled-design-302716864.html

2. Livingston R. FDA Clears MiniMed Go Smart MDI App for Adults and Children with T1D, T2D. HCPLive. January 12, 2026. https://www.hcplive.com/view/fda-clears-minimed-go-smart-mdi-app-for-adults-and-children-with-t1d-t2d