The 510(k) application covers Evie Ring's
pulse oximeter that includes heart rate and SpO2 data, and is
expected to make it one of the first consumer wearables that is
also cleared for clinical use
PLEASANTON, Calif. ,
Aug. 3,
2023 /PRNewswire/ -- Today, Movano Health
(Nasdaq: MOVE), a purpose-driven healthcare solutions company at
the intersection of medical and consumer devices and makers of the
Evie Ring, announced that it has submitted a 510(k) premarket
notification to the U.S. Food and Drug Administration (FDA) for the
Company's first commercial product, the Evie Ring. The submission
has passed the first milestone of the review process, an initial
review for completeness, and is now under full review by the
FDA.
One of the most critical components of the FDA submission is the
ring's clinical performance. In Q4 2022, Movano Health completed a
successful pivotal hypoxia trial with the University of California, San Francisco (UCSF) to
assess the accuracy of Evie's blood oxygen saturation
(SpO2). In comparing the overall accuracy of the ring's
data with data from arterial blood gas data, the Evie Ring achieved
an approximate 2% margin of error, well below the FDA guidance of
3.5% for SpO2. In a separate nonclinical test
completed by Movano Health per the standard and FDA guidance, pulse
was tested over the range of 40 to 240 beats per minute (BPM) and
the Evie Ring margin of error was 1 BPM, also exceeding FDA's
requirements.
"From the outset, our vision for Evie has been to develop a
consumer wearable that is beautiful, accessible and personalized,
as well as be cleared by the FDA as a medical device. This first
submission to the FDA marks a momentous milestone for our team
and sets the stage for future FDA filings," said John Mastrototaro, CEO of Movano Health.
"The effort associated with becoming a medical device company is
certainly significant, but we believe it's a highly competitive
differentiator and a strong asset when compared to existing
wellness solutions. It also is expected to enable significant
partnership opportunities with healthcare and other enterprises. We
look forward to working with the FDA through the review
process."
The Evie Ring combines health and wellness metrics to give a
full picture of one's health: resting heart rate, heart rate
variability, SpO2, respiration rate, skin temperature
variability, period and ovulation tracking, menstrual symptom
tracking, activity profile, including steps, active minutes and
calories burned, sleep stages and duration, and mood tracking. This
data is delivered through a mobile app which aims to simplify how
data is presented, moving away from complex graphs and charts, and
turning biometric data into actionable insights that will help
women make manageable lifestyle changes and take a more proactive
approach to mitigating the risks of chronic disease.
About Movano Health
Founded in 2018, Movano Inc. (Nasdaq: MOVE) dba Movano Health
is developing a suite of purpose-driven healthcare solutions to
bring medical-grade, high-quality data to the forefront of consumer
health devices. Featuring modern form factors, Movano Health's
devices capture a comprehensive picture of a person's vital health
information and uniquely translate the data into personalized and
intelligent insights that empower consumers to live healthier and
more balanced lives. Movano Health's end-to-end solutions will soon
enable consumers, caretakers, and healthcare professionals to
utilize daily medical-grade data as a tool to proactively monitor
and manage their health. For more information on Movano
Health, visit https://movanohealth.com/.
Forward Looking Statements
This press release contains forward-looking statements concerning
our expectations, anticipations, intentions, beliefs, or strategies
regarding the future. These forward-looking statements are based on
assumptions that we have made as of the date hereof and are subject
to known and unknown risks and uncertainties that could cause
actual results, conditions, and events to differ materially from
those anticipated. Therefore, you should not place undue reliance
on forward-looking statements. Examples of forward-looking
statements include, among others, statements we make regarding
anticipated FDA clearance for the Evie Ring, expected future
operating results; product development and features, product
releases, clinical trial, and regulatory initiatives; our
strategies, positioning and expectations for future events or
performance. Important factors that could cause actual results to
differ materially from those in the forward-looking statements are
set forth in our most recent Annual Report on Form 10-K and any
subsequent Quarterly Reports on Form 10-Q, and in our other reports
filed with the Securities and Exchange Commission, including under
the caption "Risk Factors." Any forward-looking statement in
this release speaks only as of the date of this release. We
undertake no obligation to publicly update any forward-looking
statement, whether written or oral, that may be made from time to
time, whether as a result of new information, future developments
or otherwise.
UC Disclaimer
The information stated above was prepared by Movano Health and
reflects solely the opinion of the corporation. Nothing in this
statement shall be construed to imply any support or endorsement of
Movano Health, or any of its products, by The Regents of the
University of California, its officers,
agents and employees.
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SOURCE Movano