FDA clears MiniMed’s screenless, smartphone-controlled insulin pump
MiniMed, the diabetes tech company that separated from Medtronic in early March, has received U.S. Food and Drug Administration (FDA) approval for new smartphone-controlled insulin pump.
The MiniMed Flex is smaller than previous MiniMed insulin pumps—approximately one-half the size of the 780G, and users control it with their smartphones. The next-generation, screen-free insulin pump also features the latest version of MiniMed’s SmartGuard algorithm, which automatically makes real-time insulin delivery adjustments as needed.
The MiniMed Flex was built to support the company’s new Simplera Synch sensors in addition to the Instinct sensors made in collaboration with Abbott. It also works with MiniMed’s full infusion set portfolio, including the Extended infusion set that can last up to seven days.
Image courtesy of MiniMed.
“At MiniMed, our Mission is to make every day a better day for people with diabetes,” Que Dallara, CEO of MiniMed and the former vice president of Medtronic’s diabetes business, said in a statement. “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.”
“For many people living with diabetes, the burden of daily management can be overwhelming,” added Anders Carlson, MD, medical director of the International Diabetes Center at Park Nicollet, director of the HealthPartners Diabetes Program and an assistant professor at the University of Minnesota Medical School. “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.”
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. Once the newly approved device officially hits the market, eligible customers who sign up for this program will be notified with instructions on how to proceed.
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