Therapy Areas: Diabetes
Insulet receives CE Mark approval for Omnipod 5 Automated Insulin Delivery System
20 September 2022 -

Insulet Corporation (NASDAQ: PODD), a provider of tubeless insulin pump technology with its Omnipod brand of products, reported on Tuesday that its Omnipod 5 Automated Insulin Delivery System has received CE marking under the European Medical Device Regulation.

Omnipod 5 is designed for individuals aged two years and older with type 1 diabetes and is the first CE marked tubeless hybrid closed loop system (also known as automated insulin delivery) that integrates with the Dexcom G6 Continuous Glucose Monitoring (CGM) System to automatically adjust insulin and help protect against high and low glucose levels.

The company said its system consists of the tubeless Pod enhanced with SmartAdjust technology, the Omnipod 5 Controller with its integrated SmartBolus Calculator, and the Dexcom G6 CGM.

SmartAdjust technology receives a CGM value and trend very five minutes. It predicts where glucose will be 60 minutes into the future and then increases, decreases, or pauses insulin delivery based on the user's desired and customised glucose target.

Insulet added that it expects Omnipod 5 to be available in selected countries starting mid-2023.



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