Movano Health Submits Response to FDA as Part of Final Review Phase for EvieMED
Movano Health (NASDAQ: MOVE) has submitted a complete response package to the FDA for the final review phase of its 510(k) application for the EvieMED Ring. The company remains optimistic about receiving 510(k) clearance for this wearable device. The EvieMED Ring combines medical functionality through pulse oximetry with wellness tracking features, including sleep monitoring, activity tracking, and mood and energy logging capabilities. The company sees potential opportunities in remote patient monitoring and clinical trials markets.
Movano Health (NASDAQ: MOVE) ha presentato un pacchetto di risposta completo alla FDA per la fase finale di revisione della sua domanda 510(k) per l'EvieMED Ring. L'azienda rimane ottimista riguardo al conseguimento dell'approvazione 510(k) per questo dispositivo indossabile. L'EvieMED Ring combina funzionalità mediche attraverso l'ossimetria da polso con funzionalità di monitoraggio del benessere, tra cui monitoraggio del sonno, tracciamento delle attività e registrazione dell'umore e dell'energia. L'azienda vede potenziali opportunità nei mercati del monitoraggio dei pazienti a distanza e delle sperimentazioni cliniche.
Movano Health (NASDAQ: MOVE) ha presentado un paquete de respuesta completo a la FDA para la fase final de revisión de su solicitud 510(k) para el EvieMED Ring. La compañía se muestra optimista sobre la obtención de la autorización 510(k) para este dispositivo portátil. El EvieMED Ring combina funcionalidad médica a través de la oximetría de pulso con características de seguimiento del bienestar, incluyendo monitoreo del sueño, seguimiento de actividades y capacidades de registro de estado de ánimo y energía. La empresa ve oportunidades potenciales en los mercados de monitoreo remoto de pacientes y ensayos clínicos.
Movano Health (NASDAQ: MOVE)는 EvieMED Ring의 510(k) 신청서의 최종 검토 단계에 대한 완전한 응답 패키지를 FDA에 제출했습니다. 이 회사는 이 웨어러블 장치에 대한 510(k) 승인을 받을 수 있을 것이라는 낙관적인 입장을 취하고 있습니다. EvieMED Ring은 맥박산소측정을 통한 의료 기능과 수면 모니터링, 활동 추적, 기분 및 에너지 기록 기능을 포함한 웰빙 추적 기능을 결합합니다. 이 회사는 원격 환자 모니터링 및 임상 시험 시장에서 잠재적인 기회를 보고 있습니다.
Movano Health (NASDAQ: MOVE) a soumis un dossier de réponse complet à la FDA pour la phase finale de révision de sa demande 510(k) pour la EvieMED Ring. L'entreprise reste optimiste quant à l'obtention de l'homologation 510(k) pour ce dispositif portable. La EvieMED Ring combine une fonctionnalité médicale par l'oxymétrie de pouls avec des fonctionnalités de suivi du bien-être, notamment la surveillance du sommeil, le suivi des activités et des capacités de journalisation de l'humeur et de l'énergie. L'entreprise voit des opportunités potentielles dans les marchés de la surveillance à distance des patients et des essais cliniques.
Movano Health (NASDAQ: MOVE) hat ein vollständiges Antwortpaket an die FDA für die endgültige Überprüfungsphase seines 510(k)-Antrags für den EvieMED Ring eingereicht. Das Unternehmen bleibt optimistisch, dass es die 510(k)-Freigabe für dieses tragbare Gerät erhalten wird. Der EvieMED Ring kombiniert medizinische Funktionalität durch Puls-Oximetrie mit Wellness-Tracking-Funktionen, einschließlich Schlafüberwachung, Aktivitätenverfolgung und Protokollierung von Stimmung und Energie. Das Unternehmen sieht potenzielle Möglichkeiten in den Märkten für die Fernüberwachung von Patienten und klinische Studien.
- Device combines medical functionality with wellness tracking features
- Potential market opportunities in remote patient monitoring and clinical trials
- Progress in FDA 510(k) clearance process with submission of complete response package
- FDA clearance still pending and not guaranteed
- No revenue generation until regulatory approval and market launch
Insights
The FDA response submission for EvieMED Ring's 510(k) clearance represents a critical regulatory milestone. The device's dual functionality as both a medical device (pulse oximetry) and wellness tracker positions it uniquely in the wearable market. However, several factors warrant consideration:
- 510(k) responses typically receive FDA feedback within 90 days
- Pulse oximetry clearance requires demonstration of substantial equivalence to predicate devices
- The combined medical and wellness features may require careful regulatory positioning
Company remains optimistic on the potential for this pioneering healthcare solution
"Our team has worked diligently to provide a thorough response to the Agency's questions," said John Mastrototaro, President and CEO of Movano Health. "We look forward to the successful completion of the 510(k) review process and continue to focus on the game changing opportunities that we believe EvieMED could unlock for our partners in remote patient monitoring and clinical trials."
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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SOURCE Movano
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