Friday, December 23, 2022
Owlet, Inc., announces that the U.S. Food and Drug Administration (“FDA”) has accepted for substantive review the Company’s de novo classification request seeking clearance to expand the functionality of Owlet’s Dream Sock’s existing sleep monitoring capabilities to include opportunistic heart rate and oxygen notifications, through software as a medical device that Owlet calls “Health Notifications.” 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.
“We are pleased the FDA accepted our de novo submission for substantive review. I believe FDA authorization could uniquely position Owlet to help caregivers obtain live health data so they can better address care in the home, while also increasing our ability to utilize our massive, growing data set as a critical pediatric care tool,” said Kurt Workman, Owlet President, CEO and Co-Founder. “This is our second FDA submission this year, both of which included data from clinical studies and product testing, representing years of work and dedication from our team. I am so incredibly proud of our team and look forward to FDA conducting and completing its review.”
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.