Credit: U.S. Food and Drug Administration
The U.S. Food and Drug Administration has granted 510(k) clearance to the Omnipod 5 app for iPhone.
The move, announced by Insulet Corporation on October 23, 2023, means that the Omnipod 5 automated insulin delivery (AID) system will receive FDA clearance in January 2022 for use in patients with type 1 diabetes aged 6 and older. This took place less than two years after receiving the award. With this approval, Insulet becomes the first and only company to offer a tubeless AID system that can be fully controlled from compatible Android and iOS smartphones, according to a company announcement.1,2
“Today, we celebrate this important milestone in our continued commitment to providing diabetes solutions that improve people’s lives and make them think less about diabetes,” said Executive Vice President and Chief Executive Officer said Eric Benjamin, Head of Product and Customer Experience.1 “We are excited to add the iOS platform to our mobile app offering and extend the Omnipod 5’s market-leading position in phone-controlled AID systems.”
The device will be cleared by the FDA in January 2022 for patients with type 1 diabetes aged 6 years and older, followed by approval for use in children aged 2 years and older in August 2022. As of the latter approval, Insulet has made the device the first tubeless AID with the ability to integrate with the Dexcom G6 continuous glucose monitoring system and compatible smartphone to automatically adjust insulin and protect against glycemic events. It was advertised as a system.2
According to an October 23, 2023 release from Insulet Corporation, the Omnipod 5 app for iPhone offers the same functionality as the Android app that has been available since its launch in August 2022, but with additional features and an intuitive design. has been added. This app gives all users access to new custom food features, allowing them to save carbohydrate data for their favorite foods, snacks, and meals.1
According to the release, the app will first be released through integration with the Dexcom G6 Continuous Glucose Monitoring System, with full market release expected in 2024. Once available, this app will be free to download for Omnipod 5 system users.1
References:
- Insulet announces FDA 510(k) clearance of the omnipod® 5 app for iPhone. Insulet Corporation – Insulet announces FDA 510(k) clearance of its Omnipod® 5 app for iPhone. October 23, 2023. Accessed October 24, 2023. https://investors.insulet.com/news/news-details/2023/Insulet-Announces-FDA-510k-Clearance-of-the-Omnipod-5-App-for -iPhone/default.aspx.
- Campbell P. Omnipod 5 is cleared for use in patients with type 1 diabetes who are 2 years of age and older. HCP live. August 22, 2022. Accessed October 24, 2023. https://www.hcplive.com/view/omnipod-5-receives-clearance-for-use-in-ages-2-and-older-with-type-1 – Diabetes.
