Owlet Announces FDA Software-as-a-Medical Device Submission for Heart Rate and Oxygen Displays and Notifications
23 December 2022 - 8:05AM
Business Wire
Owlet submitted a de novo classification
request to the FDA for an over-the-counter
software-as-a-medical-device that offers heart rate and oxygen
displays and notifications in conjunction with Owlet’s existing
Dream Sock sleep monitoring capabilities.
Owlet, Inc. (NYSE: OWLT) (the “Company”) 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.
Cautionary Note Regarding Forward-Looking Statements
This press release includes “forward-looking statements” within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended, under the Private Securities Litigation Reform Act of
1995. Generally, forward-looking statements include the words
“estimate,” “may,” “believes,” “plans,” “expects,” “anticipates,”
“intends,” “goal,” “potential,” “upcoming,” “outlook,” “guidance,”
the negation thereof, or similar expressions, although not all
forward-looking statements contain these identifying words. These
statements express a belief, expectation or intention and are
generally accompanied by words that convey projected future events
or outcomes. For example, statements regarding the Company’s
expectations regarding Health Notifications are forward-looking
statements. We have based these forward-looking statements on our
current expectations and assumptions, and analyses made by us in
light of our experience and our perception of historical trends,
current conditions and expected future developments, as well as
other factors we believe are appropriate under the circumstances.
However, whether actual results and developments will conform with
our expectations and predictions is subject to a number of risks
and uncertainties, many of which are beyond our control, including
the FDA’s determinations regarding regulatory and marketing
authorizations for certain of our products and the other important
factors set forth under the caption “Risk Factors” in the Company’s
Annual Report on Form 10-K for the fiscal year ended December 31,
2021, Quarterly Reports on Form 10-Q and other reports filed with
the U.S. Securities and Exchange Commission. All of the
forward-looking statements made in this press release are qualified
by these cautionary statements. The actual results or developments
anticipated may not be realized or, even if substantially realized,
may not have the expected consequences to or effects on the Company
or our business or operations. Such statements are not guarantees
of future performance, and actual results or developments may
differ materially from those projected in the forward-looking
statements. You should not place undue reliance on forward-looking
statements, which speak only as of the date they are made. We
undertake no obligation to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise, except as may be required under applicable securities
laws, although we may do so from time to time. The Company does not
endorse any projections regarding future performance, achievements
or results that may be made by third parties.
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 more
calm and confident. Owlet believes that every parent deserves peace
of mind and the opportunity to feel their well-rested best. To
learn more, visit www.owletcare.com.
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version on businesswire.com: https://www.businesswire.com/news/home/20221222005465/en/
Investors Mike Cavanaugh Westwicke/ICR
mike.cavanaugh@westwicke.com
Media Jane Putnam Owlet, Inc. jputnam@owletcare.com
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