Insulet: Automated Insulin Delivery System Omnipod 5 Gets FDA Clearance

(RTTNews) - Medical device company Insulet Corp. (PODD) announced Monday that it has received clearance from the U.S. Food and Drug Administration for its Omnipod 5 Automated Insulin Delivery System for individuals aged two years and older with type 1 diabetes or T1D.

Omnipod 5 is the first tubeless automated insulin delivery or AID system in the U.S. It was originally cleared for use in individuals aged six and older in January 2022.

The system consists of the tubeless Pod enhanced with SmartAdjust technology, the Omnipod 5 mobile app with its integrated SmartBolus Calculator, and the Dexcom G6 CGM.

The company noted that Omnipod 5 is the first tubeless AID system in the U.S. 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.

Insulet said healthcare professionals can now prescribe Omnipod 5 to their patients with insurance coverage and patients can access their prescription through the pharmacy channel, which means there is no contract and no commitment.

The Omnipod brand is the only insulin pump in the U.S. available through the pharmacy.

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