Movano Health Advances to Final Phase of FDA Review Process for EvieMED Ring
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.
Movano Health (Nasdaq: MOVE) ha fatto significativi progressi nel processo di revisione da parte della FDA per il suo EvieMED Ring, un dispositivo indossabile che offre funzionalità sia mediche che di benessere. Dopo un incontro produttivo con la FDA il 15 agosto 2024, l'azienda ha ricevuto feedback positivi sulle caratteristiche e metriche di benessere del anello. Movano Health sta ora avanzando verso la fase finale del processo di approvazione 510(k) per la funzionalità di pulse oximetry del dispositivo.
L'azienda ha presentato una domanda 510(k) aggiornata il 21 aprile 2024 e ha risposto a ulteriori richieste della FDA riguardanti gli aspetti di benessere a luglio. Inoltre, Movano Health prevede di riprendere gli ordini diretti ai consumatori (D2C) per l'Evie Ring il 17 settembre 2024, incorporando miglioramenti del prodotto e processi operativi ottimizzati.
Movano Health (Nasdaq: MOVE) ha logrado avances significativos en el proceso de revisión de la FDA para su EvieMED Ring, un dispositivo portátil que ofrece tanto funcionalidades médicas como de bienestar. Tras una reunión productiva con la FDA el 15 de agosto de 2024, la compañía recibió comentarios positivos sobre las características y métricas de bienestar del anillo. Movano Health ahora avanza hacia la fase final del proceso de aprobación 510(k) para la funcionalidad de oximetría de pulso del dispositivo.
La empresa presentó una solicitud 510(k) actualizada el 21 de abril de 2024 y respondió a consultas adicionales de la FDA sobre aspectos de bienestar en julio. Por separado, Movano Health planea reanudar los pedidos directos al consumidor (D2C) para el Evie Ring el 17 de septiembre de 2024, incorporando mejoras en el producto y procesos operativos optimizados.
모바노 헬스(Movano Health) (Nasdaq: MOVE)는 의료 및 웰니스 기능을 제공하는 웨어러블 장치인 EvieMED 링에 대한 FDA 검토 과정에서 상당한 진전을 이루었습니다. 2024년 8월 15일 FDA와의 생산적인 회의 후, 회사는 링의 웰니스 기능 및 지표에 대한 긍정적인 피드백을 받았습니다. 모바노 헬스는 이제 장치의 맥박 산소측정 기능에 대한 510(k) 승인 과정의 최종 단계로 나아가고 있습니다.
회사는 2024년 4월 21일에 업데이트된 510(k) 신청서를 제출하고, 7월에 웰니스 측면에 대한 추가적인 FDA 문의에 답변했습니다. 별도로, 모바노 헬스는 2024년 9월 17일에 Evie 링에 대한 소비자 직접 판매(D2C) 주문을 재개할 계획이며, 제품 개선 및 운영 프로세스의 개선을 통합할 예정입니다.
Movano Health (Nasdaq: MOVE) a réalisé des progrès significatifs dans le processus de révision de la FDA pour son EvieMED Ring, un dispositif portable offrant des fonctionnalités médicales et de bien-être. Suite à une réunion productive avec la FDA le 15 août 2024, l'entreprise a reçu des retours positifs sur les caractéristiques et mesures de bien-être de la bague. Movano Health avance maintenant vers la phase finale du processus de validation 510(k) pour la fonctionnalité de la pulsoxymétrie de l'appareil.
L'entreprise a déposé une demande 510(k) mise à jour le 21 avril 2024 et a répondu à des questions supplémentaires de la FDA sur les aspects bien-être en juillet. Par ailleurs, Movano Health prévoit de reprendre les commandes directes aux consommateurs (D2C) pour l'Evie Ring le 17 septembre 2024, en intégrant des améliorations de produit et des processus opérationnels optimisés.
Movano Health (Nasdaq: MOVE) hat bedeutende Fortschritte im FDA-Prüfprozess für seinen EvieMED Ring gemacht, einem tragbaren Gerät, das sowohl medizinische als auch Wellness-Funktionen bietet. Nach einem produktiven Treffen mit der FDA am 15. August 2024 erhielt das Unternehmen positives Feedback zu den Wellness-Funktionen und -metriken des Rings. Movano Health schreitet nun in die finale Phase des 510(k)-Zulassungsprozesses für die Pulsoximetriefunktion des Geräts voran.
Das Unternehmen reichte am 21. April 2024 einen aktualisierten 510(k)-Antrag ein und beantwortete im Juli zusätzliche Anfragen der FDA zu Wellness-Aspekten. Darüber hinaus plant Movano Health, am 17. September 2024 die D2C-Bestellungen für den Evie Ring wieder aufzunehmen und Produktverbesserungen sowie optimierte Betriebsprozesse zu integrieren.
- 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
- None.
Insights
The FDA meeting's positive outcome for EvieMED Ring's wellness features is a significant milestone in Movano Health's regulatory journey. This progress suggests the company has effectively addressed the FDA's concerns about non-medical functionalities, which often complicate the review process for combination devices. The focus now shifts to the pulse oximetry feature, the core medical component requiring 510(k) clearance.
The timeline—from April's updated application to August's meeting—indicates a relatively swift review process. This efficiency could be a positive sign for potential market entry. However, investors should note that final clearance is still pending and the FDA may request additional data or clarifications before granting approval.
Movano's EvieMED Ring represents a hybrid approach in the competitive wearable market, blending medical-grade functionality with wellness features. This strategy could differentiate EvieMED from consumer-focused devices like Oura Ring, potentially capturing both health-conscious consumers and those requiring medical monitoring.
The planned D2C relaunch on September 17 with enhanced features suggests confidence in the product's market readiness. This dual-track approach—pursuing FDA clearance while also targeting the consumer market—could accelerate revenue generation. However, it also presents challenges in messaging and positioning, as the company must carefully navigate claims about medical vs. wellness benefits to avoid regulatory issues.
While the FDA progress is positive, Movano Health's financial outlook remains uncertain. The company hasn't disclosed specific revenue projections or production costs for EvieMED. The renewed D2C sales could provide some near-term cash flow, but the impact on the bottom line is unclear without pricing and margin details.
Investors should watch for updates on production scalability and go-to-market strategies, especially given the planned September relaunch. The medical device market is capital-intensive and Movano may need additional funding to support full-scale production and marketing post-FDA clearance. The stock's performance may remain volatile until there's more clarity on commercialization timelines and potential partnerships or distribution channels.
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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