Movano Health Advances to Final Phase of FDA Review Process for EvieMED Ring
Rhea-AI Summary
Movano Health (Nasdaq: MOVE) has made significant progress in the FDA review process for its EvieMED Ring, a wearable device offering both medical and wellness functionalities. Following a productive meeting with the FDA on August 15, 2024, the company received positive feedback on the ring's wellness features and metrics. Movano Health is now advancing to the final phase of the 510(k) clearance process for the device's pulse oximetry feature.
The company filed an updated 510(k) application on April 21, 2024, and addressed additional FDA inquiries about wellness aspects in July. Separately, Movano Health plans to resume direct-to-consumer (D2C) orders for the Evie Ring on September 17, 2024, incorporating product enhancements and improved operations processes.
Positive
- Positive outcome from FDA meeting regarding EvieMED Ring's wellness features
- Advancement to final phase of FDA review process for 510(k) clearance
- Resumption of D2C orders for Evie Ring with product enhancements
Negative
- None.
News Market Reaction – MOVE
On the day this news was published, MOVE declined 4.17%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
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
"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
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