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The FDA has granted 510(k) Clearance to the Omnipod 5 app for iPhone, making Insulet Corporation the first to offer a tubeless AID system with smartphone control.
The US Food and Drug Administration has granted 510(k) Clearance to the Omnipod 5 app for iPhone.
Announced by Insulet Corporation on October 23, 2023, the move comes less than 2 years after the Omnipod 5 Automated Insulin Delivery (AID) system received clearance from the FDA for use in patients aged 6 years and older with type 1 diabetes in January 2022. The current clearance makes Insulet the first and only company to offer a tubeless AID system with full control from a compatible Android and iOS smartphone, according to the company’s announcement.1,2
“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,” said Eric Benjamin, Executive Vice President, Chief Product & Customer Experience Officer.1 “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.”
Cleared by the FDA for patients with type 1 diabetes aged 6 years and older in January 2022, the device would receive subsequent approval in August 2022 for use in children aged 2 years and older. At the time of the latter approval, Insulet billed the device as the first tubeless AID system with the ability to integrate with the Dexcom G6 continuous glucose monitoring system and a compatible smartphone to automatically adjust insulin and protect against glycemic events.2
According to the October 23, 2023 release from Insulet Corporation, the Omnipod 5 App for iPhone will offer the same functionality as the Android app, which has been available since the August 2022 launch, but with additional capabilities and an intuitive design. With the app, all users will be able to access a new custom food feature, which will grant them the ability to save carbohydrate data from favorite foods, snacks, or meals.1
The app will launch first with the Dexcom G6 Continuous Glucose Monitoring System integration, with a full market release expected in 2024, according to the release. Once available, the app will be available for download free of charge for users of the Omnipod 5 system.1