Insulet, a diabetes devicemaker, has received FDA clearance for its iPhone app that allows users to control their Omnipod 5 Insulin Pumps from their smartphones. This app has already been available to Android owners since the pump’s U.S. launch a year ago.
The app serves as an alternative to the Omnipod 5 controller, enabling users to manage their pump without carrying an additional device. From the app, users can perform various functions such as system setup, configuring Insulin Pods, adjusting insulin delivery settings, and administering or canceling bolus doses of insulin. It also allows monitoring of the pump’s automated insulin delivery when connected to a continuous glucose monitor, creating a closed-loop diabetes management system.
The iOS version of the app includes an exclusive feature called Custom Foods. This feature simplifies mealtime carbohydrate calculationsstoring carb counts for users’ favorite foods, making mealtime dosing easier.
Initially, the iPhone app will only be available to Omnipod 5 users who are connected to Dexcom G6 CGMs. However, it will eventually have a full market release next year. Insulet is also working on adapting the Omnipod 5 for use with Dexcom’s latest glucose sensor, the G7.
Insulet claims that this 510(k) clearance sets it apart as the first company to offer a tubeless insulin delivery system that can be fully controlledboth Android and Apple smartphones. While competitors like Medtronic and Tandem Diabetes Care have smartphone apps for their insulin pumps, they require infusion set tubing.
In conclusion, Insulet’s clearance for the Apple App allows diabetic individuals greater ease and convenience in managing their insulin pumps using their smartphones.
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Insulet Clear for Apple App to Control Insulin Pumps .
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