Following the positive outcome of a recent
agency meeting, the Company will continue to work closely with the
FDA to bring this pioneering healthcare product to market
PLEASANTON, Calif., Sept. 3,
2024 /PRNewswire/ -- Movano
Health (Nasdaq: MOVE) announced today that a
productive in-person meeting with the FDA on August 15, 2024, resulted in a positive outcome
regarding the EvieMED Ring's wellness features and metrics.
Following this development, the Company will be working with the
agency to move forward with the review process. 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.
"We are pleased that we have been able to work collaboratively
with the FDA as we continue to seek a 510(k) clearance for
EvieMED," said John Mastrototaro,
President and CEO of Movano Health. "With a positive resolution to
the ring's wellness features in hand, we look forward to completing
the final review of our submission."
On April 21, 2024, Movano Health
filed an updated 510(k) clearance application for the EvieMED
Ring's pulse oximetry feature. In late June, the FDA review
team requested additional information related to the wellness
aspects of EvieMED. In conjunction with the Company's regulatory
advisors, Movano Health provided a draft response to the FDA's
questions on July 10, 2024, and
requested a meeting with the agency to review the Company's
response. The in-person meeting with the FDA was held on
August 15, 2024.
Separately, Movano Health recently announced that it will begin
taking D2C orders again for the Evie Ring on September 17, 2024. The expanded D2C launch will
incorporate several product enhancements across sleep, activity and
insights, as well as improved operations processes.
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's proprietary technologies and wearable medical
device solutions will soon enable the 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
