MiniMed’s first app-controlled insulin pump receives CE Mark in Europe
MiniMed’s first app-controlled insulin pump has received CE Mark in Europe, bringing the company’s smallest pump design to people living with insulin-treated diabetes across the continent.
The MiniMed Flex system is around half the size of other MiniMed pumps and is the company’s most compact insulin pump to date, while still holding 300 units of insulin.
Designed to offer people greater flexibility and discretion when managing their diabetes, the system can be controlled through a smartphone app, meaning users do not need to regularly interact with the pump itself.
MiniMed said the technology has been developed to combine a smaller, more discreet design with automated insulin delivery to help diabetes management fit more easily into everyday life.
Que Dallara, CEO of MiniMed, said: “This is a proud moment for our team and an important step forward for people living with diabetes across Europe.
“We believe diabetes technology should deliver best-in-class clinical outcomes while being discreet enough to fade into everyday life.
“This milestone brings us closer to making that experience available to more people across Europe.”
The MiniMed Flex uses the company’s SmartGuard algorithm, which continuously adjusts insulin delivery using real-time glucose readings from a compatible MiniMed sensor.
It can automatically adjust and deliver correction insulin as frequently as every five minutes.
The system also features Meal Detection technology, which identifies rapid rises in sensor glucose and can provide a correction dose if a meal bolus is missed or carbohydrate intake is underestimated.
According to MiniMed, real-world results have demonstrated 80% Time in Range when recommended settings are used.
Time in Range refers to the amount of time a person’s glucose levels remain within their recommended target range and is increasingly used as an important measure of day-to-day diabetes management.
The MiniMed Flex can also be used with the company’s Extended infusion set, allowing up to seven days of wear.
Mattie Fisher, who took part in an early customer pilot of the system in the US, said: “What stands out most to me about the MiniMed Flex system is how simple and seamless it feels.
“The pump is lighter and being able to manage everything from my phone means I hardly ever interact with the pump itself.”
The MiniMed Flex has been CE marked for people aged two years and older with insulin-treated diabetes, including type 1 and type 2 diabetes. It has also received CE Mark for use during pregnancy.
MiniMed expects to begin introducing the system through a customer experience phase in selected European countries later this year.
A wider commercial launch is expected towards the end of 2026.
The company will showcase the MiniMed Flex at the European Association for the Study of Diabetes annual meeting in Milan from September 28 to October 2.
MiniMed has also announced plans for an upgrade programme in selected European countries, which will allow eligible existing and new MiniMed 780G users to enrol for an upgrade to the MiniMed Flex once it becomes commercially available in their country.