Lehi, Utah-based Owlet designed the system to enable caregivers to better care for babies at home through advanced digital technologies.
According to a news release, the now-cleared Dream Sock monitors and displays live health readings and provides health notifications. Readings include pulse rate and oxygen saturation level, while lights and alarms signal when readings fall outside of preset ranges.
Owlet plans to make the medical-grade features available to all existing and new Dream Sock users upon the coming launch. It expects that launch to begin by the end of this year. The device received clearance for use with healthy infants between 1-18 months and 6-30 pounds.
The company previously received FDA clearance for its BabySat prescription monitoring system. BabySat uses pulse oximetry in a wire-free sock design, much like the Dream Sock that requires no prescription. It originally submitted BabySat for FDA 510(k) clearance in October 2022.
“Today marks a significant breakthrough in our journey to bring care to the home and empower parents with an unprecedented FDA-clearance for the Owlet Dream Sock,” said Kurt Workman, Owlet CEO and co-founder. “This accomplishment not only signifies our commitment to innovation in the infant health category but, more importantly, our dedication to ensuring the health and well-being of every baby.
“With this de novo clearance, we are proud to set new standards in at-home infant care, arming parents with reliable real-time information and providing enhanced peace of mind.”
