MiniMed has announced FDA clearance for MiniMed Flex™, a compact, smartphone-controlled insulin pump designed for everyday use.
The device is about half the size of the MiniMed™ 780G pump and roughly the size of two stacked insulin vials.
It is MiniMed’s first screenless pump, developed with input from people living with diabetes to offer a more intuitive, lifestyle-friendly way to manage the condition.
MiniMed Flex™ is powered by the company’s advanced SmartGuard™ algorithm with Meal Detection™ technology, delivering automated insulin delivery performance that meets global Time in Range recommendations.
The pump features a 300-unit reservoir, allowing it to be worn discreetly in a pocket or out of sight. It is fully managed through a mobile app on iOS and Android devices, eliminating the need for a pump screen and allowing seamless software updates.
At launch, it will support MiniMed’s newest sensor portfolio, including the Simplera Sync™ sensor and Abbott’s Instinct sensor, and works with extended infusion sets that can be worn for up to seven days, reducing injections by up to 96% compared with traditional insulin therapy. Real-world results have shown up to 80% Time in Range when used with recommended settings.
MiniMed Flex™ is cleared for individuals aged 7 and older with type 1 diabetes, and adults with insulin-requiring type 2 diabetes.
The device will first launch in a limited customer experience phase this spring, with a wider commercial release planned for summer. The MiniMed™ Forward Program allows current MiniMed™ 780G users to upgrade to MiniMed Flex™ at no additional cost, providing a smooth transition to the new system.
