MiniMed has received clearance from the US Food and Drug Administration (FDA) for its latest insulin delivery device, MiniMed Flex. The new system is a compact, smartphone-controlled insulin pump designed to make diabetes management less visible and easier to handle in everyday life.

The device marks a major shift in design for the company. It is about half the size of the MiniMed 780G pump and comes without a traditional screen. Instead, it is fully managed through a mobile application, allowing users to control and monitor insulin delivery directly from their smartphones. The idea is to reduce the constant attention typically required for diabetes care and allow the system to function more quietly in the background.

MiniMed Flex is powered by the company’s advanced SmartGuard algorithm, which includes Meal Detection technology. This system automatically adjusts insulin delivery based on glucose levels and patterns, helping users maintain better control. Clinical and real-world data suggest that the technology can achieve around 80 Percent Time in Range, which aligns with global recommendations for diabetes management.

The pump is designed to be both discreet and practical. It offers a 300-unit insulin capacity despite its smaller size, making it suitable for a wide range of patient needs. It can be worn in different ways, including being kept out of sight, which many users may prefer. The system also works with extended infusion sets that can be worn for up to seven days, significantly reducing the number of injections compared to traditional insulin therapy.

At launch, MiniMed Flex will be compatible with the company’s latest sensor portfolio, including the Simplera Sync sensor and the Instinct sensor developed by Abbott. This integration is aimed at creating a more seamless and connected diabetes management experience.

According to company leadership, the device has been developed in close collaboration with people living with diabetes, focusing on simplicity and ease of use. The goal is to reduce the daily burden of managing the condition while maintaining consistent clinical outcomes.

Medical experts have also highlighted the potential of the system. By combining a discreet design with automated insulin delivery and smartphone control, the device could help improve adherence, confidence, and overall treatment outcomes for patients. It is expected to be particularly useful for those who find traditional pump systems complex or intrusive.

MiniMed has also introduced the MiniMed Forward Programme, which will allow existing users of the MiniMed 780G system to upgrade to MiniMed Flex at no additional cost, subject to eligibility. This is intended to make the transition easier for current users already familiar with the company’s ecosystem.

The rollout will begin with a limited customer experience phase involving select users, followed by a wider commercial launch in the United States later in the year. The system is approved for individuals aged seven years and older with type 1 diabetes, and for adults with insulin-dependent type 2 diabetes.

Overall, the MiniMed Flex system represents a step forward in making diabetes technology more user-friendly, discreet, and integrated into daily life, while continuing to rely on advanced automation to support better health outcomes.