MiniMed Gains FDA Clearance for Half-Size Flex Pump with 300-Unit Reservoir
MiniMed received FDA clearance for its half-size, smartphone-controlled Flex pump, featuring a 300-unit reservoir and SmartGuard adaptive algorithm with Meal Detection. The pump supports Simplera Sync and Abbott Instinct sensors, delivers 80% Time in Range performance, and offers a $0 upgrade path for 780G users via the Forward Program.
1. FDA Clearance of MiniMed Flex
MiniMed secured FDA clearance for its Flex pump, its first smartphone-controlled, screenless insulin delivery device and a major redesign of the 780G system. This approval underscores the company’s commitment to next-generation diabetes technology soon after its public market debut.
2. Innovative Design and Performance Features
Flex is roughly half the size of the 780G pump, houses a 300-unit insulin reservoir, and runs on the SmartGuard adaptive algorithm with Meal Detection technology. Real-world trials demonstrated 80% Time in Range performance, and the pump will support both Simplera Sync and Abbott Instinct sensors at launch.
3. Forward Program and Commercial Rollout
The MiniMed Forward Program enables existing 780G users to upgrade to Flex at no additional cost. A limited customer experience phase begins this spring, with a broader commercial rollout planned for summer for individuals ages 7+ with type 1 diabetes and adults with insulin-requiring type 2 diabetes.