Company remains optimistic on the potential
for this pioneering healthcare solution
PLEASANTON, Calif., Nov. 4, 2024
/PRNewswire/ -- Movano
Health (NASDAQ: MOVE) announced today that it
has submitted a complete response package to the FDA as part of the
final phase of the Company's 510(k) application review of the
EvieMED Ring. The Company remains optimistic on EvieMED's potential
for 510(k) clearance.
"Our team has worked diligently to provide a thorough response
to the Agency's questions," said John
Mastrototaro, President and CEO of Movano Health. "We look
forward to the successful completion of the 510(k) review process
and continue to focus on the game changing opportunities that we
believe EvieMED could unlock for our partners in remote patient
monitoring and clinical trials."
The EvieMED Ring is a wearable device designed to not only
provide medical device functionality through its pulse oximetry
feature, but also offer numerous wellness metrics related to sleep,
activity and logging of mood, energy and other
characteristics.
About Movano Health
Founded in 2018,
Movano Inc. (NASDAQ: MOVE) dba Movano
Health, maker of the Evie Ring
(www.eviering.com), is developing a suite of
purpose-driven healthcare solutions to bring medical-grade data to
the forefront of wearables. Featuring modern and flexible form
factors, Movano Health's devices offer an innovative
approach to delivering trusted data to both customers and
enterprises, capturing a comprehensive picture of an individual's
health data and uniquely translating it into personalized and
intelligent insights.
Movano Health is developing its proprietary technologies and
wearable medical device solutions to enable the future use of data
as a tool to proactively monitor and manage health outcomes across
a number of patient populations that exist in healthcare. 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 plans with
respect to the commercial launches of the Evie Ring and EvieMED
Ring; our expectations regarding potential commercial
opportunities; planned cost-cutting initiatives; anticipated FDA
clearance decisions with respect to our products; expected future
operating results; product development and features, product
releases, clinical trials 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.
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SOURCE Movano