Insulet Corporation Receives FDA 510(k) Clearance for the Omnipod® 5 App on iPhone

Insulet Corporation, a global pioneer in tubeless insulin pump technology, has acquired FDA 510(k) clearance for the Omnipod 5 App for iPhone. This success cements Insulet’s position as the sole vendor of a tubeless automated insulin delivery (AID) system, with complete control available via Android and iOS smartphones.

“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. 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,” said Eric Benjamin, Executive Vice President, Chief Product & Customer Experience Officer.

Following its complete rollout in the United States in August 2022, the Omnipod 5 Automated Insulin Delivery System has provided smartphone control for customers with compatible Android smartphones. The technology will soon be accessible through compatible iPhones, allowing customers to manage the device straight from their phone.

Crafted for user convenience, the Omnipod 5 App for iPhone presents enhanced features and a user-friendly interface, aligning with the existing Android version. It introduces a custom foods feature, allowing users to store carbohydrate data for frequently consumed foods, snacks, and meals.

The Omnipod 5 App for iPhone will be released in 2024, initially connecting with the Dexcom G6 Continuous Glucose Monitoring System. When the iPhone App becomes available, Omnipod 5 System users will have free access to it.

Individuals with type 1 diabetes considering Omnipod 5 can consult their healthcare providers for initiation on the system. The upcoming Omnipod 5 App for iPhone will seamlessly accommodate users with compatible devices. Insulet plans to communicate the release date to the diabetes community in due course.

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