On Nov. 9, 2023, Owlet announced it received De Novo clearance from the FDA for its Dream Sock, an over-the-counter medical pulse oximetry solution for infants. The device provides infants’ real-time health information to parents and caregivers.
About the Owlet Dream Sock
According to Owlet, the Dream Sock will monitor and display an infant’s health information, including pulse rate and oxygen saturation level. The non-prescription device will provide notifications with lights and alarm sounds to alert caregivers if an infant’s readings fall outside preset ranges. These features are for use in healthy infants aged one to 18 months and between six to 30 pounds. The Owlet Dream Sock was clinically tested in home and hospital environments.
The announcement of De Novo clearance for the Dream Sock follows Owlet’s previous FDA clearance of BabySat, a prescription monitoring system that uses pulse oximetry technology and a wire-free sock design. BabySat is intended for infants with acute or chronic medical conditions under the supervision of a physician.
The FDA-cleared features are expected to roll out to new and existing Dream Sock users by the end of 2023 in the U.S. only.
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