Owlet, Inc. announced that the U.S. Food and Drug Administration (ôFDAö) has accepted for substantive review the CompanyÆs de novo classification request seeking clearance to expand the functionality of OwletÆs Dream SockÆs 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.