Company continues to work with FDA to bring
this pioneering healthcare product to market
PLEASANTON, Calif., Aug. 5, 2024
/PRNewswire/ -- Movano
Health (Nasdaq: MOVE) plans to meet with the
FDA in mid-August, as part of the Company's ongoing process to
secure a 510(k) clearance for the EvieMED Ring, a wearable designed
to not only provide medical device functionality through its pulse
oximetry feature, but also offer numerous wellness metrics related
to sleep, activity and mood/energy/symptom logging. On April 21, 2024, Movano Health filed an
updated 510(k) for the EvieMED Ring's pulse oximetry feature. At
the time of the filing and based on prior interactions with the
agency and its protocols, the Company indicated it could
potentially receive a regulatory decision by July 2024.
Subsequent to the filing, in May and early June, two minor
clarifications were requested by the FDA review team and promptly
completed by Movano Health. 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 draft
response. Given the FDA's internal calendar, the agency has since
scheduled the meeting with the Company for mid-August. Movano
Health looks forward to meeting with the FDA and working
towards resolving the matter related to the inclusion of
EvieMED's wellness aspects in order to move forward with
the review process.
"Although we understand that 510(k) regulatory review timelines
can vary based on the agency's summer calendar, we remain steadfast
in our commitment to the opportunity EvieMED could unlock, given
the clinical evidence provided as part of the filing related to the
pulse oximetry feature and our desire to work collaboratively with
the agency," said John Mastrototaro,
CEO and President of Movano Health.
The Company will report second quarter 2024 financial and
operating results on Wednesday, August 14,
2024, after the market close. Management will host a
conference call and live audio webcast to discuss these results and
provide a business update on the same day at 2:00 pm PT/5:00 pm
ET. Attendees can access the live webcast here or on
the investors section of Movano Health's website at
https://ir.movano.com.
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; 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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/movano-health-provides-progress-update-on-eviemed-regulatory-filing-302213912.html
SOURCE Movano
