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MiniMed wins FDA clearance for next-gen Flex insulin pump

March 18, 2026 By Sean Whooley

MiniMed Flex insulin pump system worn on the arm
The Flex pump worn at the hip. [Image courtesy of MiniMed]
MiniMed (Nasdaq:MMED) announced today that it received FDA clearance for the MiniMed Flex next-generation insulin pump.

Flex, a discreet, smartphone-controlled insulin pump, was designed by the company — which just went public as part of its separation from Medtronic — to seamlessly fit into everyday life. Clearance covers individuals aged 7 and older with type 1 diabetes and individuals 18 and older with insulin-requiring type 2 diabetes.

The MiniMed Flex (8 series) pump is much smaller than the previous-generation 780G (about half the size), allowing for more discrete placement while still using the same reservoirs and infusion sets. It will work with both the Simplera Sync and Instinct (made by Abbott) sensors. MiniMed submitted the pump to the FDA during the third quarter.

According to the company, the pump comes in at roughly the size of two stacked insulin vials. It says Flex offers its first screenless design, created in partnership with people living with diabetes. The company aimed to deliver an intuitive, lifestyle-friendly way to manage the condition. MiniMed’s SmartGuard algorithm with Meal Detection technology powers the pump.

“At MiniMed, our mission is to make every day a better day for people with diabetes,” said Que Dallara, CEO 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.”

MiniMed also has the Fit patch pump under development — learn more about that here.

More about the MiniMed Flex pump

The company says that Flex represents a “major redesign” of its insulin pumps.

MiniMed Flex insulin pump system product image
A marketing image of the Flex pump system. [Image courtesy of MiniMed]
Key features include the small, sleek design that still enables high insulin capacity. Its design enables users to wear it wherever they prefer, whether in a pocket, out of sight, or elsewhere. The pump still delivers a 300-unit insulin reservoir to support a range of insulin needs.

Smartphone control through a compatible mobile app eliminates the traditional pump screen, the company says. It also offers seamless software updates through both iOS and Android devices at launch. The pump also has compatibility across two sensor options at launch to provide choices for users.

Flex works with MiniMed’s infusion set portfolio, including its Extended infusion set with up to seven days of wear. This enables up to 96% fewer injections compared with traditional insulin therapy, according to the company.

Meanwhile, MiniMed said Flex provides proven automated insulin delivery performance, with real-world evidence highlighting 80% time in range with recommended settings.

“MiniMed Flex represents an important leap forward for MiniMed,” said Dr. Anders Carlson, 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. 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.”

More about the device launch

MiniMed said that it intends to launch a new program that enables a seamless upgrade from the 780G pump to the Flex system.

The MiniMed Forward Program allows customers who start on 780G to switch to Flex for $0. This applies to those who purchased a 780G system between February 18, 2026, and launch. New 780G users who enroll in the program will be notified when Flex becomes commercially available and receive instructions for completing the upgrade.

MiniMed plans to launch Flex this spring through an initial customer experience phase with select customers. It then plans for a broader launch in the summer.

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Patient Monitoring, Regulatory/Compliance, Technology Tagged With: FDA, Medtronic, minimed

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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