Owlet, Inc. announced De Novo clearance from the U.S. Food and Drug Administration (?FDA?) of Dream Sock, the first and only over-the-counter medical pulse oximetry solution for infants. Owlet is spearheading new standards for consumer and medical solutions, allowing caregivers to provide better care at home for their babies through access to advanced digital health technologies. The FDA-cleared Dream Sock will monitor and display Baby?s Live Health Readings, including pulse rate and oxygen saturation level, and will provide Health Notifications, which will alert caregivers with lights and alarm sounds if their infant?s readings fall outside of preset ranges.

Owlet plans to make these new medical-grade features available to all existing and new Dream Sock users upon launch, soon to be announced. These cleared features are for use with healthy infants between 1-18 months and 6 lbs to 30 lbs. 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.

This new technology will equip caregivers with the right information at the right time, and provide them with confidence and clarity on their baby?s well-being. This follows the Company?s previous FDA clearance of BabySat, a prescription monitoring system that uses pulse oximetry technology and features a modern, wire-free sock design. 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.

BabySat will be available for purchase with insurance reimbursement soon. Now, Owlet?s clinically-validated technology and notification algorithms are available for use with healthy babies without a prescription. These 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.