Movano Health Plans Response Submission to FDA Next Week as Part of EvieMED Final Review Phase
Movano Health (Nasdaq: MOVE) announced plans to submit responses next week to FDA's clarifying questions regarding their 510(k) application for EvieMED. The company previously received positive feedback on EvieMED's wellness features and metrics this summer. The EvieMED Ring is designed as a wearable device combining medical functionality through pulse oximetry with wellness metrics tracking for sleep, activity, mood, and energy. The company aims to provide a consumer-friendly solution for remote patient monitoring and clinical trials to improve patient compliance and data collection.
Movano Health (Nasdaq: MOVE) ha annunciato piani per presentare le risposte la prossima settimana alle domande chiarificatrici della FDA riguardo la loro richiesta 510(k) per EvieMED. L'azienda ha ricevuto in precedenza feedback positivi sulle funzionalità e le metriche di benessere di EvieMED quest'estate. L'EvieMED Ring è progettato come un dispositivo indossabile che combina funzionalità mediche attraverso la pulsossimetria con il monitoraggio delle metriche di benessere per sonno, attività, umore ed energia. L'azienda mira a fornire una soluzione adatta ai consumatori per il monitoraggio remoto dei pazienti e le sperimentazioni cliniche, al fine di migliorare la compliance dei pazienti e la raccolta dei dati.
Movano Health (Nasdaq: MOVE) anunció planes para enviar respuestas la próxima semana a las preguntas aclaratorias de la FDA sobre su solicitud 510(k) para EvieMED. La empresa recibió comentarios positivos sobre las características y métricas de bienestar de EvieMED este verano. El EvieMED Ring está diseñado como un dispositivo portátil que combina funcionalidad médica a través de la oximetría de pulso con el seguimiento de métricas de bienestar para el sueño, la actividad, el estado de ánimo y la energía. La empresa tiene como objetivo ofrecer una solución amigable para los consumidores para el monitoreo remoto de pacientes y ensayos clínicos, con el fin de mejorar la adherencia de los pacientes y la recopilación de datos.
Movano Health (Nasdaq: MOVE)는 EvieMED의 510(k) 신청서에 대한 FDA의 명확한 질문에 대한 답변을 다음 주에 제출할 계획이라고 발표했습니다. 이 회사는 올여름 EvieMED의 웰니스 기능 및 지표에 대한 긍정적인 피드백을 받았습니다. EvieMED 링은 맥박 산소 측정을 통해 의료 기능과 수면, 활동, 기분, 에너지에 대한 웰니스 지표 추적을 결합한 착용 가능한 장치로 설계되었습니다. 이 회사는 원격 환자 모니터링 및 임상 시험을 위한 소비자 친화적인 솔루션을 제공하여 환자 준수 및 데이터 수집을 개선하는 것을 목표로 하고 있습니다.
Movano Health (Nasdaq: MOVE) a annoncé des plans pour répondre la semaine prochaine aux questions de clarification de la FDA concernant leur demande 510(k) pour EvieMED. L'entreprise a précédemment reçu des commentaires positifs sur les fonctionnalités et les métriques de bien-être d'EvieMED cet été. La Bague EvieMED est conçue comme un dispositif portable combinant des fonctionnalités médicales grâce à la pléthysmographie par pouls et le suivi des métriques de bien-être pour le sommeil, l'activité, l'humeur et l'énergie. L'entreprise vise à fournir une solution conviviale pour le suivi à distance des patients et les essais cliniques afin d'améliorer la conformité des patients et la collecte de données.
Movano Health (Nasdaq: MOVE) gab Pläne bekannt, nächste Woche auf die klärenden Fragen der FDA zu ihrer 510(k)-Anmeldung für EvieMED zu antworten. Das Unternehmen hatte in diesem Sommer bereits positives Feedback zu den Wellnessfunktionen und -metriken von EvieMED erhalten. Der EvieMED Ring ist als tragbares Gerät konzipiert, das medizinische Funktionen durch Puls-Oximetrie mit Wellnessmetriken zur Überwachung von Schlaf, Aktivität, Stimmung und Energie kombiniert. Das Unternehmen verfolgt das Ziel, eine verbraucherfreundliche Lösung für die Fernüberwachung von Patienten und klinische Studien anzubieten, um die Patientencompliance und die Datenerfassung zu verbessern.
- Previous positive resolution from FDA regarding wellness features
- Product combines medical functionality with wellness tracking
- Potential market opportunity in remote patient monitoring and clinical trials
- 510(k) clearance still pending FDA approval
- Additional clarifying questions from FDA requiring response
Insights
The FDA response submission for EvieMED represents a critical regulatory milestone for Movano Health. Previous successful resolution of wellness features questions indicates positive momentum, though final clearance remains uncertain. The 510(k) pathway suggests the device will be classified as a Class II medical device, requiring demonstration of substantial equivalence to a predicate device.
The pulse oximetry functionality positions EvieMED in the remote patient monitoring space, where regulatory compliance is essential. The combination of medical and wellness features in a ring form factor is relatively unique, which could impact the review timeline. While the company appears confident, FDA clearance processes typically take 3-6 months after final submissions, assuming no additional information requests.
A successful response to requests for additional information would bring the Company one step closer to introducing this pioneering healthcare product to the market
"We are pleased that we will be submitting a timely and thorough response to the Agency's questions and look forward to the successful completion of the 510(k) review process," said John Mastrototaro, President and CEO of Movano Health. "We believe EvieMED will be a game changing device for our partners in remote patient monitoring and clinical trials, as they look for a consumer-friendly solution to bolster patient compliance and better data collection."
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.
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 is developing its proprietary technologies and wearable medical device solutions to enable the future 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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