Company plans to file for FDA clearance of a
new wearable that provides women with medical grade data and
personalized actionable insights to track and manage overall
health
PLEASANTON, Calif., Dec. 28,
2022 /PRNewswire/ -- Movano Health (Nasdaq: MOVE), a
purpose-driven healthcare solutions company at the intersection of
medical and consumer devices, today announces its smart ring, Evie.
Designed specifically for women, Evie is sleek, intelligent, and
comfortable, providing users with medical grade health data that's
translated into personalized insights delivered through a mobile
app, with no monthly subscription.
![Renderings of the Evie Ring - the first medical grade smart ring designed uniquely for women. Renderings of the Evie Ring - the first medical grade smart ring designed uniquely for women.](https://mma.prnewswire.com/media/1973509/Movano_Evie_Smart_Rings.jpg)
Movano Health is planning to seek FDA clearance for Evie, which
will make it the first consumer wearable that is also a medical
device. The Company plans to file for pulse oximetry metrics after
having completed a successful hypoxia trial in October 2022, where accuracy for clinical
SpO2 and heart rate commensurate with FDA's consensus
standard was demonstrated. While a few wearables are only FDA
cleared for specific software, such as ECG and Afib, Evie is
designed per regulatory standards and built in a medical device
manufacturing facility that meets ISO13485 and cGMP standards. The
clearance will offer women trusted and personalized insights that
can help them draw connections between cause and effect, so they
can better understand the "why" behind what they're feeling.
Additionally, Evie will deliver data that clinicians can deem
reliable for patient care.
Evie 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. For example, Evie uses
medical grade heart rate and SpO2 data to help identify
patterns in her sleep quality and trends in her menstrual cycle, so
she can understand her body's natural baseline and over time learn
how to feel her best. Because a successful day looks different for
every woman, the solution places as much emphasis on recovery as it
does activity and encourages women to set goals related to both
physical and mental health.
"As a medical device, Evie will go beyond the status quo of
other wearables on the market, and we believe it has the power to
transform women's lives and overall health," said Dr. John Mastrototaro, CEO of Movano Health. "We are
bringing together medical grade biometric data and insights in a
comfortable and contemporary wearable that allows women to take
ownership of their unique health journey."
Evie will be unveiled during CES 2023 alongside a demo
showcasing its features and allowing consumers to gather live heart
rate and SpO2 level readings within the app. It is made
of polished aluminum and will come in three different finishes. The
ring will be available in sizes 5-11, and its open design
allows for a comfortable fit. The smart ring is expected to cost
under $300 with no added monthly
subscription fees and will be available in 2023.
For more information about the Evie Ring, visit
EvieRing.com.
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.
Movano Health's Evie Ring, which is specifically designed
to address women's health concerns, will debut at CES
2023 and will be available for purchase in mid-2023. For
more information on Movano Health, visit www.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 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.
![Evie logo Evie logo](https://mma.prnewswire.com/media/1973510/Evie_Logo_Logo.jpg)
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SOURCE Movano