Insulet’s Omnipod 5 cleared for use ages two and up
By HME News Staff
Updated 9:56 AM CDT, Wed August 24, 2022
ACTON, Mass. – Insulet has received U.S. Food and Drug Administration clearance for its Omnipod 5 Automated Insulin Delivery System for individuals aged two years and older with Type 1 diabetes. “We received tremendous first-hand reports of how Omnipod 5 made diabetes management easier for our pivotal trial participants, and the clinical data demonstrated impressive glycemic improvements, as well,” said Dr. Trang Ly, MBBS, FRACP, PhD, Insulet’s senior vice president and medical director. “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 5 is a tubeless system 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 system consists of the tubeless Pod enhanced with SmartAdjustT technology, the Omnipod 5 mobile app with integrated SmartBolus Calculator, and the Dexcom G6 CGM.
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