FDA Approves Insulet's Omnipod Automated Insulin System For Patients Two Years & Above

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  • The FDA has cleared Insulet Corporation's PODD Omnipod 5 Automated Insulin Delivery System for individuals aged two years and older with type 1 diabetes (T1D). 
  • Omnipod 5 is tubeless automated insulin delivery (AID) system in the U.S. that was initially cleared for use in individuals aged six and older in January 2022.
  • Also Read: Insulet Posts Q2 Revenue Beat, Lifts FY22 Guidance.
  • In a recent publication by Sherr et al. in Diabetes Care, Omnipod 5 significantly improved time in range and reduced HbA1c and time in hypoglycemia (<70 mg/dL) in very young children (aged 2 – 5.9 years) with type 1 diabetes. 
  • Related: Insulet Highlights New Data For Omnipod 5 System For Type 1, Type 2 Diabetes.
  • Healthcare professionals can now prescribe Omnipod 5 to their patients with insurance coverage. Patients can access their prescription through the pharmacy channel, meaning there is no contract or commitment. 
  • Price Action: PODD shares closed at $267.42 on Friday.
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