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FDA clearance of Omnipod 5 automated insulin delivery system, first tubeless system with Smartphone control

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Published:3rd Feb 2022
Insulet Corporation ,the global leader in tubeless insulin pump technology with its Omnipod brand of products, announced it has received clearance from the FDA for its Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for individuals aged six years and older with type 1 diabetes.

Omnipod 5 is the first tubeless automated insulin delivery (AID) system that integrates with the Dexcom G6 Continuous Glucose Monitoring (CGM) System and a compatible smartphone to automatically adjust insulin and help protect against highs and lows.

Omnipod 5 Automated Insulin Delivery System is designed to make it easier than ever to manage glucose with no multiple daily injections, no tubes, and zero fingersticks to help simplify life with diabetes.

The Omnipod 5 System consists of the tubeless Pod enhanced with SmartAdjust technology, the Dexcom G6 CGM, and the Omnipod 5 mobile app with its integrated SmartBolus Calculator. The user has the option to download this app onto a compatible personal smartphone or to use the Omnipod 5 Controller, which is provided free with the first prescription.Every five minutes, SmartAdjust receives a Dexcom CGM value and trend, and predicts where glucose will be 60 minutes into the future. The system then increases, decreases, or pauses insulin delivery using the user’s desired and customized glucose target, helping to protect against highs and lows.

Omnipod 5 will launch through the pharmacy channel, providing customer benefits of no contract, no commitment, and no obligation. In the coming days, Insulet will offer Omnipod 5 in a limited market release so that the Company can incorporate learnings to deliver a best-in-class product experience. Omnipod 5 is expected to be broadly available shortly after the limited market release.

Condition: Diabetes Types 1 & 2
Type: drug

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