Insulet (Nasdaq:PODD) announced today that the FDA granted 510(k) clearance for its Omnipod 5 App for iPhone.
Clearance makes Insulet the only company offering a tubeless, automated insulin delivery (AID) system with full control from a compatible Android and iOS smartphone. The company first launched the system, compatible with Android devices, in August 2022.
Insulet Chief Technology Officer Mark Field said last week that the company believed this regulatory nod would come imminently. Presenting during a session at DeviceTalks West in Santa Clara, California, Field explained how Insulet brought Omnipod 5 to market.
“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, EVP, chief product & 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.”
Insulet can now offer users controllability of their Omnipod 5 from their compatible iPhone. It gives them more options for those who prefer not to carry an extra device, as Insulet offers its own controller.
The Omnipod 5 App for iPhone delivers the same functionality as the Android app, the company said. It also has additional capabilities and an intuitive design. Users can access a new custom foods feature and safe carbohydrate data for favorite foods, snacks or meals consumed frequently.
Insulet plans to launch its iPhone app first with Dexcom G6 continuous glucose monitor (CGM) integration. It expects a full market release in 2024 and users can download the iPhone app free of charge once available.
The analyst’s view on the latest good news from Insulet
BTIG analysts Marie Thibault and Sam Eiber responded to the news by maintaining their “Buy” rating for Insulet.
“This is a significant win in our view, since it enables a more convenient patient experience by removing the need to carry a separate controller,” they wrote. “Patients using the app will also have access to a new custom foods feature with the ability to save carbohydrate data for favorite foods or meals that are consumed frequently.”
The analysts made no changes to their estimates for Insulet. They plan to have more on the company when it reports its third-quarter financial results on Nov. 2.