FDA Clears Insulet Corp.’s Automated Insulin Delivery System

Jan 28, 2022 By MarketDepth

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FDA Approval

Insulet Corporation (NASDAQ: PODD) received clearance from the U.S. Food and Drug Administration (FDA) for its Omnipod® 5 Automated Insulin Delivery System.

Up over 12%

Shares of Insulet Corporation (NASDAQ: PODD) gained over 12.9% during the premarket trading session following the announcement. 

Type 1 Diabetes

The Omnipod 5, intended for individuals aged six years and older with type 1 diabetes, is designed to make it easier to manage glucose without multiple daily injections, tubes, or fingersticks. 

“As the pioneer of integrated CGM, we are excited to see our years of collaborative work with Insulet culminate into the first and only FDA-cleared tubeless automated insulin delivery system. Omnipod 5 combines the accuracy and unmatched user experience of the Dexcom G6 CGM with the simplicity of tubeless insulin delivery to offer people with diabetes a revolutionary new way to optimize time in range.”

Kevin Sayer, Chairman, President and CEO of Dexcom

Omnipod 5 was a CES® 2022 Innovation Award honoree in two categories: Health and Wellness as well as Wearable Technologies, and in the near future, Insulet will offer Omnipod 5 in a limited market release.