FDA Approves Insulet's Omnipod Automated Insulin Delivery System Patients Aged 6 Years & Above

The FDA has cleared Insulet Corporation's PODD Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for patients aged six years of age and older with type 1 diabetes.

  • Omnipod 5 is the first tubeless automated insulin delivery system integrated with the Dexcom G6 Continuous Glucose Monitoring System.
  • It is compatible with a smartphone to adjust insulin and help protect against highs and lows automatically. 
  • The system makes it easier to manage glucose with no multiple daily injections, tubes, or finger sticks.
  • Related: Insulet's Insulin Delivery System Shows Durable Glycemic Control With One Year of Use.
  • SmartAdjust receives a Dexcom CGM value and trend every 5 minutes and predicts glucose levels in 60 minutes. 
  • The system then increases, decreases, or pauses insulin delivery using a customized glucose target, which helps avoid highs and lows in insulin levels.
  • Price Action: PODD shares are up 16.2% at $226.39 during the market session on the last check Friday.
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