Insulet: FDA Approves Enhancements To Omnipod 5 Algorithm

(RTTNews) - Insulet (PODD) announced it has received FDA 510(k) clearance for significant enhancements to the Omnipod 5 Automated Insulin Delivery System. The new 100 mg/dL Target Glucose expands Omnipod 5's customization range to six settings between 100-150 mg/dL in 10 mg/dL increments. The updates to the Omnipod 5 algorithm are projected to launch in the United States in the first half of 2026, where Omnipod 5 is cleared for people aged 2 and older with type 1 and aged 18 and older with type 2 diabetes.

"This is the most significant algorithm advancement to our Omnipod 5 System since its launch in 2022," said Eric Benjamin, Insulet COO.

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