Owlet, Inc. Announces FDA Software-As-A-Medical Device Submission for Heart Rate and Oxygen Displays and Notifications
December 22, 2022 at 04:05 pm
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Owlet, Inc. announced that the U.S. Food and Drug Administration (ôFDAö) has accepted for substantive review the CompanyÃs de novo classification request seeking clearance to expand the functionality of OwletÃs Dream SockÃs existing sleep monitoring capabilities to include opportunistic heart rate and oxygen notifications, through software as a medical device that Owlet calls ôHealth Notifications.ö Designed for parents and caregivers to monitor healthy babies at home, the Health Notifications software would provide displays of live heart rate and oxygen saturation for babies, in addition to the opportunistic notifications when these readings move beyond certain ranges.
The de novo 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 ineligible for the 510(k) pre-market notification process. The Health Notifications software is a novel approach with the goal of opportunistically providing parents and caregivers with data and notifications to supplement their decisions in providing care at home or seeking guidance for medical care for their babies. In October 2022, Owlet also announced the submission of a 510(k) pre-market notification for a prescription-only monitor designed to be used in-home for babies under the supervision of a physician.
Owlet, Inc. operates as a digital parenting platform company. The Company's platform focuses on giving real-time data and insights to parents. Its products include Owlet Dream Sock, an app to assist children with better sleep; Owlet Cam, a video streaming app to hear and see the baby from anywhere, and Owlet Monitor Duo. The Company offers sock monitor offerings, which include Smart Sock and Dream Sock and Dream Sock Plus. Its Cam offerings include Cam 1 and Cam 2. Its Monitor Duo and Dream Duo offer Sock Monitor offerings paired with the Owlet Cam offerings, combining the intelligence of its Sock Monitor offerings with high-definition video, offering parents the most complete picture of their babyâs sleep. Its accessories product line includes the Owlet Sleeper, a wearable rayon blanket that encourages safe sleep, best for babies ages three-six months old, and an Owlet Sock Travel Case.