Insulet has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Omnipod 5 App for iPhone, making Insulet the first company to offer a tubeless automated insulin delivery (AID) system with full control from a compatible Android and iOS smartphone.
“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 and customer experience officer, “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. Since its full commercial launch in August 2022, the Omnipod 5 Automated Insulin Delivery System has included the option for smartphone control for customers using compatible Android devices. The Omnipod 5 App for iPhone will launch first with the Dexcom G6 Continuous Glucose Monitoring System ICRM) integration, with a full market release in 2024 in the US, other countries to follow. Users of the Omnipod 5 System can download the iPhone App free of charge once available.”
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