
Insulet Corporation Achieves FDA Clearance for Omnipod 5 App for iPhone
Insulet Corporation announced that it has secured FDA 510(k) clearance for the Omnipod 5 App for iPhone, making it the first and only company to offer a tubeless automated insulin delivery (AID) system with complete control from a compatible Android and iOS smartphone. The Omnipod 5 Automated Insulin Delivery System (Omnipod 5) was fully commercialized in the United States in August 2022, offering smartphone control for users with compatible Android devices. The device was FDA approved in January 2022 for individuals with type one diabetes six or older and there are approximately 1.6 million individuals in the United States with type one diabetes.
The Omnipod 5 App for iPhone has been designed with user convenience in mind and mirrors the functionality of its Android counterpart, while also introducing additional capabilities and an intuitive design. Notably, users will gain access to a new custom foods feature, enabling the saving of carbohydrate data for frequently consumed favorite foods, snacks, or meals. The Omnipod 5 App for iPhone is set to launch initially with integration for the Dexcom G6 Continuous Glucose Monitoring System, with a full market release planned for 2024. The Omnipod 5 Pod is enhanced with a control algorithm called SmartAdjust technology which assesses data from the continuous glucose monitor and and predicts where glucose will be 60 minutes into the future allowing for automated insulin adjustments.
Eric Benjamin, Executive Vice President, Chief Product & Customer Experience Officer, stated, “Today, we celebrate this significant milestone in our ongoing effort to provide people with diabetes solutions that improve their lives and help them think less about diabetes. We are thrilled to add the iOS platform to our mobile app offerings and elevate Omnipod 5’s market-leading position in phone-controlled AID systems.”