FDA Clears MiniMed's Smallest Insulin Pump

The screenless device is controlled using a smartphone.

Mini Med Flex System Meal
MiniMed

MiniMed has received FDA clearance for MiniMed Flex, a smartphone-controlled insulin pump.

About half the size of the MiniMed 780G pump and roughly the size of two stacked insulin vials, MiniMed Flex is the company's first screenless design. At commercial launch, MiniMed Flex will support the company's newest sensor portfolio, including Simplera Sync sensor and the Instinct sensor, made by Abbott.

MiniMed Flex represents a major redesign of MiniMed's insulin pumps. Features include:

  • Small design with high insulin capacity: Designed to be worn wherever users prefer — in a pocket or out of sight — while delivering a 300-unit insulin reservoir to support a range of insulin needs.
  • Smartphone-controlled: Managed through a compatible mobile app, eliminating the traditional pump screen, with seamless software updates delivered through iOS and Android devices at launch.
  • Sensor compatibility: At commercial launch, MiniMed Flex will support the company's newest sensor portfolio, including Simplera Sync sensor and the Instinct sensor, made by Abbott.
  • Extended infusion set options: Works with MiniMed's infusion set portfolio, including the Extended infusion set with up to 7 days of wear, delivering up to 96% fewer injections compared with traditional insulin therapy.
  • Proven AID performance: Real-world results have demonstrated 80% Time in Range with recommended settings.
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