After months of regulatory delays, Insulet has secured a CE Mark for its Omnipod 5, its automated Insulin Delivery System for individuals aged two years and older with Type 1 diabetes.
The tubeless hybrid closed loop system integrates with the Dexcom G6 continuous glucose monitoring system to automatically adjust insulin delivery. The receipt of the CE Mark under the European Union’s Medical Device Regulations comes weeks after the Food and Drug Administration approved it for use in children aged two years and upwards in the USA.
Insulet expects to use the CE Mark to make the device available in ‘select countries’ including the UK from the middle of 2023 onward.
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