MiniMed launches smallest app-controlled insulin pump in the U.S.
MiniMed launched the MiniMed Flex system in the U.S., its smallest app-controlled insulin pump, featuring the SmartGuard algorithm and Simplera Sync sensor. The FDA-cleared device holds 300 units of insulin and adjusts delivery every 5 minutes to maintain glucose levels.
*this image is generated using AI for illustrative purposes only.
MiniMed announced the commercial launch of the MiniMed Flex system in the United States, introducing its first app-controlled insulin pump and the smallest device in its portfolio. The system is designed to offer clinical performance while integrating into users' lifestyles through smartphone control. It launches alongside the Simplera Sync sensor, a disposable all-in-one sensor with a two-step insertion process.
The MiniMed Flex system is powered by the SmartGuard algorithm, which features Meal Detection technology to address rapid rises in sensor glucose. The system automatically adjusts and autocorrects insulin delivery every 5 minutes based on real-time readings from the Simplera Sync sensor. Real-world results indicate an 80% Time in Range (TIR) with recommended settings, exceeding worldwide recommendations.
Key Features and Specifications
The device is approximately half the size of the MiniMed 780G pump while maintaining a 300-unit insulin capacity. It is compatible with the Extended infusion set, allowing for up to seven days of wear. This compatibility can result in up to 96% fewer injections compared to traditional insulin therapy, which assumes four injections per day for 30 days.
| Feature | Description |
|---|---|
| Insulin Capacity | 300 units |
| Adjustment Frequency | Every 5 minutes |
| Infusion Set Wear | Up to 7 days |
| Sensor | Simplera Sync |
Regulatory Approval and Availability
The MiniMed Flex system is FDA cleared for individuals with type 1 diabetes aged 7 years and older, as well as adults aged 18 years and older with insulin-requiring type 2 diabetes. A version of the system paired with the Instinct sensor, made by Abbott, is currently investigational and not commercially available in the U.S.
Que Dallara, chief executive officer of MiniMed, stated that the device allows users to prioritize their lives without sacrificing therapy effectiveness. Reimbursement support and access programs are available through MiniMed's customer support team.
How will the MiniMed Flex system impact the competitive landscape of app-controlled insulin pumps in the U.S. market?
What are the potential challenges in securing widespread insurance reimbursement for the new system?
Could the success of the MiniMed Flex accelerate the adoption of similar app-controlled diabetes management devices globally?
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