PR Newswire·Mar 18, 2026, 9:06 AM ET

MiniMed Announces FDA Clearance of MiniMed Flex™, the Company's Smallest Insulin Pump Featuring Its First Smartphone-Controlled Design

MiniMed received FDA clearance on March 18, 2026, for the MiniMed Flex™, a next-generation insulin pump that is approximately half the size of the MiniMed™ 780G system.
The device features a screenless, compact design with a 300-unit insulin reservoir, allowing it to be worn discreetly in a pocket or out of sight.
MiniMed Flex™ is smartphone-controlled via iOS and Android apps and utilizes the SmartGuard™ adaptive algorithm with Meal Detection™ technology for real-time insulin delivery adjustments.
At commercial launch, the pump will support the Simplera Sync™ sensor and the Abbott Instinct sensor.
The system is indicated for individuals aged 7 and older with type 1 diabetes, and those aged 18 and older with insulin-requiring type 2 diabetes.
MiniMed launched the MiniMed™ Forward Program, offering a $0 upgrade for eligible MiniMed™ 780G users who purchased their system between February 18, 2026, and the launch date.
The product will enter a customer experience phase in spring 2026, followed by a broader commercial launch in summer 2026.
Clinical data cited in the announcement indicates the system achieves 80% Time in Range with recommended settings.
The pump is compatible with MiniMed's Extended™ infusion set portfolio, which allows for up to 7 days of wear per set.