Dive Brief:
- Insulet has received 510(k) clearance from the Food and Drug Administration for its Omnipod 5 application on iPhone, which allows people to control their insulin pump from a smartphone.
- Insulet included an Android app when it first launched its Omnipod 5 pump last year. The iPhone app has the same functions with a few new features.
- The clearance is significant because it removes the need for patients to carry a separate controller, BTIG analyst Marie Thibault wrote in a research note.
Dive Insight:
Insulet said the clearance would make it the first company to offer a tubeless automated insulin delivery system that can be controlled by an app on Android or iPhone.
In the past, pumps have required a separate controller to adjust insulin doses. Tandem Diabetes Care said it was the first company to offer a smartphone app for bolus insulin dosing last year, when it received FDA clearance for iPhone and Android apps that could be used with its t:slim X2 pump. The company now offers a smaller Mobi insulin pump that can be controlled by an Android phone.
Insulet said its iPhone app offers the same functionality as its Android app, with a few new capabilities. For example, users can save carbohydrate data for favorite foods or meals that they eat frequently.
Insulet plans first to offer the iPhone app with the Dexcom G6 continuous glucose monitoring system integration and expects a full market release in 2024.