MiniMed Flex Smartphone-Controlled Insulin Pump Wins FDA Nod

MiniMed has obtained U.S. Food and Drug Administration (FDA) clearance for MiniMed Flex, a next-gen discreet, smartphone-controlled insulin pump.

The pump is about half the size of the MiniMed 780 and about the size of two stacked insulin vials. MiniMed Flex is the company’s first screenless design created in partnership with people living with diabetes.

It’s powered by the company’s most advanced SmartGuard algorithm with Meal Detection technology. At launch, the company will support its newest sensor portfolio, including Simplera Sync and the Instinct sensor made by Abbott.

Its small, sleek design with high insulin makes it designed to be worn in a pocket or out of sight while delivering a 300-unit insulin reservoir. A compatible mobile app removes the need for the traditional pump screen and updates will be delivered through iOS and Android devices at launch.

MiniMed Flex works with the company’s infusion set portfolio, including the Extended infusion set with up to seven days of wear. The company said this provides up to 96% fewer injections compared to traditional insulin therapy. The company also said real-world results have shown 80% Time in Range with recommended settings.

“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.”

Last month, the company launched its MiniMed Go Smart MDI system with the Simplera sensor in Europe. According to MiniMed, the system is the first and only solution to integrate data from the InPen smart insulin pen and the Simplera sensor into one mobile app.