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Omnipod 5 App for iPhone Receives FDA 510(k) Clearance

Nov 16, 2023
Danatech Staff
Insulet Corporation has received FDA clearance for its Omnipod 5 App for iPhone, becoming the first company to offer a tubeless automated insulin delivery system with complete control via compatible Android and iOS smartphones. It will integrate with the Dexcom G6 Continuous Glucose Monitoring System initially, with a full market release in 2024, and is available at no cost to Omnipod 5 System users.

Insulet Corporation has received its long anticipated FDA clearance for its Omnipod 5 App for iPhone, becoming the first company to offer a tubeless automated insulin delivery system with complete control via compatible Android and iOS smartphones.

This approval enhances the Omnipod 5's position in phone-controlled AID systems, with the iPhone app offering the same features as its Android counterpart. The app includes a custom foods feature, allowing users to save carbohydrate data for frequently consumed items. It will integrate with the Dexcom G6 Continuous Glucose Monitoring System initially, with a full market release in 2024, and is available at no cost to Omnipod 5 System users. This development provides greater convenience for individuals managing type 1 diabetes.

For more info, view Insulet's full press release

View OmniPod5 specifications

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