The Company continues to work closely with the
FDA to bring this pioneering healthcare product to market
PLEASANTON, Calif., Oct. 10,
2024 /PRNewswire/ -- Movano
Health (Nasdaq: MOVE) announced today that the
Company recently received additional clarifying questions from the
FDA related to medical aspects of the EvieMED Ring, as part of the
final phase of the Company's 510(k) application review process. The
Company secured a positive resolution this summer after responding
to initial FDA questions related to EvieMED's wellness features and
metrics and remains optimistic on EvieMED's potential for 510(k)
clearance.
"The FDA 510(k) clearance process is a rigorous one and we are
pleased with the progress we continue to make," said John Mastrototaro, President and CEO of Movano
Health. "We are confident we can effectively address the follow up
questions that the Agency has submitted, and we look forward to
completing the final review of the EvieMED Ring."
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.
Separately, Movano Health announced that it successfully
commenced taking direct-to-consumer (D2C) orders again for the Evie
Ring on September 17, 2024. With a
fully organic marketing campaign, the Company is pleased with the
initial response to product and operational improvements, including
enhanced sleep, heart rate and activity monitoring, expanded
AI-generated personalized insights, and upgrades across
manufacturing, logistics and customer service.
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