Owlet Receives FDA De Novo Classification For Infant Dream Sock®, Shares Rise 30%
NEW YORK, NY - November 14, 2023 - Smart infant monitoring company, Owlet, Inc. (NYSE: OWLT), has received De Novo clearance from the FDA for its Dream Sock® medical pulse oximetry solution for infants. The company’s Dream Sock product will monitor and display infants’ live health readings, including pulse rate and oxygen saturation level, and will alert caregivers if their infant’s readings fall outside of preset ranges. Owlet’s share price rose 31% in intraday trading on Monday.
Kurt Workman, Owlet Chief Executive Officer and Co-Founder, said, “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. 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.”
Achieving De Novo clearance means the Owlet Dream Sock was clinically tested in both home and hospital environments, and proven to be as accurate as medical-grade baby monitoring technology and compliant with all relevant performance and safety standards by independent laboratories.
Owlet’s BabySat™ prescription monitoring system that uses pulse oximetry technology and features a modern, wire-free sock design previously received FDA clearance. BabySat is intended for infants with acute or chronic medical conditions under the supervision of a physician, BabySat provides a real-time display of a baby’s pulse rate and oxygen saturation level, and alerts parents when these customizable readings fall outside of prescribed ranges.
The Dream Sock’s new FDA-cleared features will begin rolling out to both existing and new Dream Sock users by the end of this year, in the U.S. only.
About Owlet, Inc.
Owlet was founded by a team of parents in 2012. Owlet’s mission is to empower parents with the right information at the right time, to give them more peace of mind and help them find more joy in the journey of parenting. Owlet’s digital parenting platform aims to give parents real-time data and insights to help parents feel calmer and more confident. Owlet believes that every parent deserves peace of mind and the opportunity to feel their well-rested best. Owlet also believes that every child deserves to live a long, happy, and healthy life, and is working to develop products to help further that belief. To learn more, visit www.owletcare.com.
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