Insulet Announces FDA Clearance of the Omnipod 5 App for iPhone

The Omnipod 5 App for iPhone will launch first with the Dexcom G6 Continuous Glucose Monitoring System integration.

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Insulet

Insulet today announced it has received FDA 510(k) clearance for the Omnipod 5 App for iPhone, making Insulet the first and only company to offer a tubeless automated insulin delivery (AID) system with full control from a compatible Android and iOS smartphone.

“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, Executive Vice President, 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.”

Since its full commercial launch in August 2022 in the United States, the Omnipod 5 Automated Insulin Delivery System (Omnipod 5) has included the option for smartphone control for customers using compatible Android devices. With today’s announcement, the Omnipod 5 Pod will soon be controllable from a compatible iPhone, providing even more options for users who prefer not to carry an extra device.

Designed with users in mind, the Omnipod 5 App for iPhone offers the same functionality as the Omnipod 5 App for Android, plus additional capabilities, and an intuitive design. Users will have access to a new custom foods feature with the ability to save carbohydrate data for favorite foods, snacks, or meals that are consumed frequently.

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. Users of the Omnipod 5 System can download the iPhone App free of charge once available.

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