FDA Expands 510(k) Clearance to Insulet’s Omnipod 5 to Include Younger Children

The FDA has expanded its clearance of Insulet’s Omnipod 5 automated insulin delivery system to include children two years and older with type 1 diabetes.

The tubeless insulin delivery system integrates with the Dexcom G6 continuous glucose monitor and a compatible smartphone to automatically adjust insulin and help protect against high and low glucose levels.

Healthcare professionals can now prescribe Omnipod 5 to their patients with insurance coverage and patients can access their prescription through the pharmacy channel. The device is the only insulin pump available through the pharmacy in the U.S.

In January, the device was cleared for children six years and older with type 1 diabetes.