Owlet Announces FDA-Clearance of the First Prescription Pulse Oximetry Sock for Infants
June 20 2023 - 8:30AM
Business Wire
Owlet (NYSE: OWLT, “the Company”), the pioneer of smart baby
monitoring, announces clearance from the U.S. Food and Drug
Administration (“FDA”) of BabySat™, the first medical
pulse-oximetry device featuring its advanced, wire-free sock
design. Owlet is a leader in infant health data, having monitored
more than 1 million babies, and with BabySat, combines its
consumer-first expertise with hospital-grade monitoring
accuracy.
“Our mission is to provide caregivers with the right information
at the right time to make informed decisions about their baby’s
health,” said Kurt Workman, Chief Executive Officer and Co-Founder.
“Today, parents whose babies need additional monitoring are sent
home with traditional solutions that can be restrictive and more
cumbersome for parents. BabySat pushes forward the modernization of
hospital-grade technology for at-home use, and underscores our
commitment to transforming baby care solutions.”
Innovation in the baby care space matters because some of the
largest issues facing caregivers and healthcare providers have yet
to be solved. For example, there are roughly 92 million infant care
visits covering a child’s first four years of life, significantly
straining the availability of hospital beds and quality of
care.
BabySat is a step forward in solving some of these exact
challenges by bringing real-time medical grade infant monitoring
into the home, while under the supervision of a physician.
Available through prescription, BabySat uses pulse oximetry
technology to provide a real-time display of their baby’s heart
rate and oxygen saturation level (SpO2) and alerts parents when
these readings fall outside of prescribed ranges. With access to
this information and under the supervision of a physician,
caregivers are enabled to feel confident in providing at-home care
for their families–helping to reduce the strain on our valued
medical resources.
The addition of the FDA-cleared BabySat device expands on
Owlet’s existing portfolio of consumer products designed to bring
peace of mind to caregivers. BabySat will be available in the U.S.
only and is targeted to launch later this year. Customers can learn
more and sign up to receive the latest information and details on
product availability here:
https://www.owletcare.com/babysat-fda-clearance
About Owlet, Inc.
Owlet was founded by a team of parents in 2012. Owlet’s mission
is to empower parents with the right information at the right time,
to give them more peace of mind and help them find more joy in the
journey of parenting. Owlet’s digital parenting platform aims to
give parents real-time data and insights to help parents feel
calmer and more confident. Owlet believes that every parent
deserves peace of mind and the opportunity to feel their
well-rested best. Owlet also believes that every child deserves to
live a long, happy, and healthy life, and is working to develop
products to help further that belief. To learn more, visit
www.owletcare.com.
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version on businesswire.com: https://www.businesswire.com/news/home/20230620203966/en/
Media Contact: pr@owletcare.com
Healthcare Contact: Jim Fidacaro
jfidacaro@owletcare.com
Investor Contact: Mike Cavanaugh Westwicke/ICR Phone:
+1.617.877.9641 mike.cavanaugh@westwicke.com
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