Insulet has secured a CE Mark for its Omnipod 5 Automated Insulin Delivery System in 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 expanded the label for the device by approving it for use in children aged two years and up.
Insulet expects to use the CE Mark to make the device available in “select countries” from the middle of next year onward.
The company increased its 2022 forecast for revenue growth range after early success for Omnipod 5. Insulet moved Omnipod 5 into a full release in the U.S. on Aug. 1 after performing a limited launch for several months.
