Insulet’s Omnipod 5 iPhone App Wins FDA OK

Insulet Corporation has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Omnipod 5 App for iPhone.
 
The company said this clearance makes it the first and only company with a tubeless, automated insulin delivery (AID) system with full control from a compatible Android and iOS smartphone. The Omnipod 5 App for iPhone offers the same functionality as the app for Android—plus additional capabilities, Insulet said. Users will have access to a new custom foods feature to save carbohydrate data for favorite foods, snacks, or meals that are consumed frequently.
 
The iPhone app will first roll out with the Dexcom G6 continuous glucose monitoring (CGM) system integration, with full release to the market in 2024. The integrated system entered the German market in September, and the U.K. market in August.
 
“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,” Insulet’s executive VP, chief product and customer experience officer Eric Benjamin told the press. “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.”
 
The Omnipod AID system was first launched in the U.S. in August 2022.