Owlette is de novo FDA Classification Request for Software as an Over-the-Counter Medical Device Providing Heart Rate and Oxygen Display and Notification It works in conjunction with Owlet’s existing Dream Sock sleep monitoring feature.
Lehi, Utah, December 22, 2022–(BUSINESS WIRE)–Owlet, Inc. (NYSE: OWLT) (the “Company”) is licensed by the U.S. Food and Drug Administration (“FDA”) to de novo A classified request for permission to extend the functionality of Owlet’s Dream Sock’s existing sleep monitoring capabilities to include opportunistic heart rate and oxygen notifications through software that Owlet calls “Health Notifications” as a medical device. Designed to help parents and caregivers monitor healthy babies at home, Health Notifications software displays your baby’s live heart rate and oxygen saturation, and alerts you when these measurements exceed certain ranges. Provides occasional opportunistic notifications.
“We are delighted that the FDA has accepted our approval. de novo Submission for Substantial Review. With FDA approval, Owlet will enable caregivers to capture live health data so they can better address home care, while leveraging vast data sets as a critical pediatric care tool I believe it will increase our capabilities,” Kurt Workman said. President, CEO and Co-Founder of Owlet. “This is our second FDA submission this year, and both include data from clinical studies and product trials, and represent years of hard work and dedication from our team.” I am very proud of our team and look forward to the FDA conducting and completing the review.”
of de novo A pathway for marketing authorization is available for low- to moderate-risk medical devices that do not have a legally marketed predicate device and are therefore not subject to the 510(k) premarket notification process. Health Notifications software aims to provide parents and caregivers with opportunistic data and notifications to supplement their decisions when providing care at home or seeking medical care guidance for their baby is a new approach.
In October 2022, Owlet also announced the submission of a 510(k) Premarket Notice for prescription-only monitors designed for home use for babies under the supervision of a physician.
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About Owlette Co., Ltd.
Owlet was founded in 2012 by a team of parents. Owlet’s mission is to provide parents with the right information at the right time, giving them peace of mind and helping them find more joy in their parenting journey. Owlet’s digital parenting platform aims to provide parents with real-time data and insights to help them feel more calm and confident. Owlet believes that every parent deserves the opportunity to experience peace of mind and the best rest.
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