A successful response to requests for
additional information would bring the Company one step closer to
introducing this pioneering healthcare product to the
market
PLEASANTON, Calif., Oct. 24,
2024 /PRNewswire/ -- Movano
Health (Nasdaq: MOVE) announced today that it plans
to submit updated responses next week to all clarifying questions
that it recently received from the FDA as part of the final phase
of the Company's 510(k) application review. 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.
"We are pleased that we will be submitting a timely and thorough
response to the Agency's questions and look forward to the
successful completion of the 510(k) review process," said
John Mastrototaro, President and CEO
of Movano Health. "We believe EvieMED will be a game changing
device for our partners in remote patient monitoring and clinical
trials, as they look for a consumer-friendly solution to bolster
patient compliance and better data collection."
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