FDA Clears Insulet's Omnipod 5 Automated Insulin Delivery System For Preschool Children

The U.S. Food and Drug Administration (FDA) has announced clearance to Insulet’s PODD Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for individuals aged two years and older with type 1 diabetes (T1D).

Omnipod 5 is the first tubeless AID system in the United States that integrates with the Dexcom G6 CGM system and a compatible smartphone to automatically adjust insulin and help protect against high and low glucose levels.

The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. It is the only insulin pump in the United States available through the pharmacy

Dr. Trang Ly, Senior Vice President and Medical Director, commented : "This expanded indication for younger children gives us great pride, knowing we can further ease the burden of glucose management for these children and their caregivers with our simple to use, elegant, automated insulin delivery system.”

Omnipod was previously cleared for use in individuals aged six and older in January 2022.

Price Action: Insulet shares traded higher at $268.38 on Friday’s after-hour session.