Insulet’s Automated Insulin Delivery System Cleared

Acton, Mass.-based Insulet has received the FDA’s 510(k) clearance for its Omnipod 5 automated insulin delivery system for people age six and up with type 1 diabetes.

The Omnipod 5 system integrates with Insulet’s SmartAdjust software, Dexcom’s G6 continuous glucose monitoring system and a smartphone app to automatically adjust the user’s insulin dose.

The SmartAdjust software receives a measurement from the monitoring system every five minutes and predicts where glucose will be 60 minutes into the future. The system then increases, decreases or pauses insulin delivery based on the user’s desired glucose target.

Insulet said it will initially offer Omnipod 5 on a limited basis in the U.S. market.