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Dear Owlet Family, As the CEO and co-founder of Owlet, I am happy to share the biggest milestone in Owlet’s history and one that sets a new standard for infant care at home. Today, Owlet announced FDA Clearance of Dream Sock, the first and only over-the-counter medical pulse-oximetry device for infants. For the first time ever, Owlet’s clinically-validated technology and notification algorithms are available for use with healthy babies without a prescription. This is the culmination of years of clinical research and rigorous testing and I could not be more proud to share this news with you. Here’s what this means for babies and caregivers: - This new FDA clearance will allow Dream Sock users to track their infant’s Live Health Readings, including pulse rate and oxygen saturation level.
- The clearance includes Owlet’s new Health Notifications, which will alert parents with lights and alarm sounds if their baby’s health readings fall outside of preset ranges.
- 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.
- Intended for use with healthy infants between 1-18 months and 6-30 lbs.
- These new FDA-cleared features will begin rolling out to both existing and new Dream Sock users by the end of this year.
To get more details on this announcement, I invite you to read our official press release and visit our website to learn more and sign-up for updates. It is an honor to be a part of your parenting journey. Thank you for your continued support on our mission to improve the safety and health of every baby, and deliver peace of mind to every parent. With heartfelt gratitude, Kurt Workman CEO & Co-Founder, Owlet | | Available in the US only. | | | | | Owlet Baby Care 3300 N. Ashton Blvd, Suite 300 Lehi, Utah 84043 © 2023 | All rights reserved.
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