Insulet’s Omnipod 5 app for iPhone granted FDA 510(k) clearance

Insulet has received FDA 510(k) clearance for the Omnipod 5 App for iPhone, offering a tubeless automated insulin delivery system with full control from a compatible Android and iOS smartphone. Since its commercial launch in August 2022 in the U.S., the Omnipod 5 Automated Insulin Delivery System has included the option for smartphone control for customers using compatible Android devices. The Omnipod 5 Pod will soon be controllable from a compatible iPhone. The Omnipod 5 App for iPhone will launch first with the Dexcom G6 Continuous Glucose Monitoring System integration, with a full market release in 2024.