Movano Health Provides Progress Update on EvieMED Regulatory Filing
Movano Health (Nasdaq: MOVE) is progressing with its FDA 510(k) clearance process for the EvieMED Ring, a wearable device offering both medical and wellness functionalities. The company filed an updated 510(k) for the ring's pulse oximetry feature on April 21, 2024, initially expecting a decision by July 2024. After addressing minor clarifications in May and June, the FDA requested additional information about EvieMED's wellness aspects in late June.
Movano Health provided a draft response on July 10 and is scheduled to meet with the FDA in mid-August to discuss the inclusion of wellness features in the device. CEO John Mastrototaro expressed confidence in the clinical evidence provided for the pulse oximetry feature and the company's commitment to collaborating with the FDA. The company will report its Q2 2024 financial results on August 14, 2024.
Movano Health (Nasdaq: MOVE) sta avanzando con il processo di approvazione 510(k) della FDA per l'EvieMED Ring, un dispositivo indossabile che offre sia funzionalità mediche che di benessere. L'azienda ha presentato un aggiornamento del 510(k) per la funzione di ossimetria da polso il 21 aprile 2024, inizialmente prevedendo una decisione entro luglio 2024. Dopo aver affrontato alcune piccole chiarificazioni a maggio e giugno, la FDA ha richiesto ulteriori informazioni sugli aspetti di benessere di EvieMED a fine giugno.
Movano Health ha fornito una bozza di risposta il 10 luglio ed è programmata per un incontro con la FDA a metà agosto per discutere l'inclusione delle funzionalità di benessere nel dispositivo. Il CEO John Mastrototaro ha espresso fiducia nelle evidenze cliniche fornite per la funzione di ossimetria da polso e nell'impegno dell'azienda a collaborare con la FDA. L'azienda riporterà i risultati finanziari del secondo trimestre 2024 il 14 agosto 2024.
Movano Health (Nasdaq: MOVE) está avanzando en su proceso de aprobación 510(k) por parte de la FDA para el EvieMED Ring, un dispositivo portátil que ofrece tanto funcionalidades médicas como de bienestar. La compañía presentó una actualización del 510(k) para la función de oximetría de pulso el 21 de abril de 2024, esperando inicialmente una decisión para julio de 2024. Después de abordar aclaraciones menores en mayo y junio, la FDA solicitó información adicional sobre los aspectos de bienestar de EvieMED a finales de junio.
Movano Health proporcionó un borrador de respuesta el 10 de julio y está programada para una reunión con la FDA a mediados de agosto para discutir la inclusión de funciones de bienestar en el dispositivo. El CEO John Mastrototaro expresó confianza en la evidencia clínica presentada para la función de oximetría de pulso y en el compromiso de la compañía para colaborar con la FDA. La compañía anunciará sus resultados financieros del segundo trimestre de 2024 el 14 de agosto de 2024.
모바노 헬스(Movano Health, Nasdaq: MOVE)는 의료 및 웰빙 기능을 제공하는 웨어러블 장치인 EvieMED 링에 대한 FDA 510(k) 승인 절차를 진행 중입니다. 회사는 2024년 4월 21일에 링의 맥박산소측정 기능에 대한 업데이트된 510(k)를 제출했으며, 당초 2024년 7월까지 결정을 예상했습니다. 5월과 6월에 약간의 미비점을 해소한 후, FDA는 6월 말에 EvieMED의 웰빙 측면에 대한 추가 정보를 요청했습니다.
모바노 헬스는 7월 10일에 초안 응답을 제공했으며, 웰빙 기능의 장치 포함에 대해 논의하기 위해 8월 중순에 FDA와 회의할 예정입니다. CEO인 존 마스트로타로(John Mastrototaro)는 맥박산소측정 기능에 대한 임상 증거에 대한 자신감을 표현하며, FDA와의 협력에 대한 회사의 약속을 강조했습니다. 회사는 2024년 2분기 재무 결과를 2024년 8월 14일에 발표할 예정입니다.
Movano Health (Nasdaq: MOVE) avance dans son processus d'approbation 510(k) par la FDA pour l'EvieMED Ring, un dispositif portable offrant à la fois des fonctionnalités médicales et de bien-être. L'entreprise a déposé une mise à jour du 510(k) pour la fonction d'oxymétrie de pouls le 21 avril 2024, s'attendant initialement à une décision d'ici juillet 2024. Après avoir traité des clarifications mineures en mai et juin, la FDA a demandé des informations supplémentaires sur les aspects de bien-être d'EvieMED fin juin.
Movano Health a fourni un projet de réponse le 10 juillet et doit rencontrer la FDA à la mi-août pour discuter de l'inclusion des fonctionnalités de bien-être dans le dispositif. Le PDG John Mastrototaro a exprimé sa confiance dans les preuves cliniques fournies pour la fonction d'oxymétrie de pouls et l'engagement de l'entreprise à collaborer avec la FDA. L'entreprise annoncera ses résultats financiers du deuxième trimestre 2024 le 14 août 2024.
Movano Health (Nasdaq: MOVE) macht Fortschritte bei dem Genehmigungsprozess 510(k) der FDA für den EvieMED Ring, ein tragbares Gerät, das sowohl medizinische als auch Wellness-Funktionen bietet. Das Unternehmen hat am 21. April 2024 eine aktualisierte 510(k) für die Pulsoxymetriefunktion des Rings eingereicht, und zunächst wurde eine Entscheidung bis Juli 2024 erwartet. Nach der Bearbeitung kleiner Klarstellungen im Mai und Juni forderte die FDA Ende Juni weitere Informationen zu den Wellness-Aspekten von EvieMED an.
Movano Health legte am 10. Juli einen Entwurf der Antwort vor und wird Mitte August mit der FDA zusammentreffen, um die Aufnahme der Wellness-Funktionen in das Gerät zu erörtern. CEO John Mastrototaro äußerte Vertrauen in die klinischen Beweise für die Pulsoxymetriefunktion und das Engagement des Unternehmens zur Zusammenarbeit mit der FDA. Das Unternehmen wird seine Finanzzahlen für das zweite Quartal 2024 am 14. August 2024 bekanntgeben.
- Movano Health is actively progressing with the FDA 510(k) clearance process for EvieMED Ring
- The company promptly addressed FDA's requests for clarifications
- Movano Health has secured a meeting with the FDA in mid-August to discuss the product
- The regulatory decision timeline has been extended beyond the initially expected July 2024 date
- Additional information requested by FDA regarding wellness aspects, potentially complicating the approval process
The FDA's request for additional information on EvieMED's wellness aspects introduces a potential delay in the 510(k) clearance process. This is not uncommon but could impact Movano Health's timeline. The company's proactive approach in seeking a meeting with the FDA is positive, demonstrating their commitment to collaboration.
However, the lack of a clear timeline for resolution is concerning. The distinction between medical and wellness features in wearable devices is a growing regulatory challenge. This situation highlights the evolving nature of FDA regulations for multi-function devices, which could have broader implications for the wearable health tech industry.
Investors should monitor the outcome of the mid-August meeting closely, as it will be important in determining the path forward for EvieMED's regulatory approval and potential market entry.
Movano Health's EvieMED Ring represents a significant market opportunity in the rapidly growing wearable health tech sector. The device's dual functionality as both a medical and wellness tool positions it uniquely in the market. However, the regulatory hurdles it's facing could give competitors an advantage in time-to-market.
The company's
On the positive side, the pulse oximetry feature, if approved, could open doors to reimbursement opportunities and medical partnerships, potentially setting EvieMED apart from consumer-focused competitors. The market's reaction to this news will likely be cautious, balancing the product's potential against regulatory uncertainties.
Company continues to work with FDA to bring this pioneering healthcare product to market
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.
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SOURCE Movano
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