Movano Health Receives FDA Clearance for EvieMED Ring
Movano Health has received FDA 510(k) clearance for the pulse oximeter in its EvieMED Ring, opening up a $40 billion healthcare B2B market opportunity. The clearance enables the company to pursue opportunities in clinical trials, post-clinical management, and remote patient monitoring. The company is already in agreement phase with a large payor for a pilot study planned for early 2025 and in discussions with pharmaceutical companies and CROs. The EvieMED Ring combines medical-grade accuracy with comfortable wearability, measuring blood oxygen levels, heart rate, and additional wellness metrics. A pivotal study confirmed accurate readings across all skin tones.
Movano Health ha ricevuto l'approvazione FDA 510(k) per il pulsossimetro integrato nel EvieMED Ring, aprendo opportunità nel mercato B2B della salute del valore di 40 miliardi di dollari. Questa approvazione consente all'azienda di esplorare possibilità in studi clinici, gestione post-clinica e monitoraggio remoto dei pazienti. L'azienda è già in fase di accordo con un grande payor per uno studio pilota previsto per inizio 2025 ed è in trattativa con aziende farmaceutiche e CRO. L'EvieMED Ring combina precisione di grado medico con indossabilità confortevole, misurando i livelli di ossigeno nel sangue, la frequenza cardiaca e ulteriori metriche di benessere. Uno studio cruciale ha confermato letture accurate su tutti i toni di pelle.
Movano Health ha recibido la aprobación de la FDA 510(k) para el oxímetro de pulso en su EvieMED Ring, abriendo una oportunidad de mercado B2B en atención médica valorada en 40 mil millones de dólares. La aprobación permite a la empresa buscar oportunidades en ensayos clínicos, gestión post-clínica y monitoreo remoto de pacientes. La empresa ya está en fase de acuerdo con un gran pagador para un estudio piloto planificado para principios de 2025 y en discusiones con empresas farmacéuticas y CRO. El EvieMED Ring combina precisión de grado médico con comodidad de uso, midiendo los niveles de oxígeno en sangre, frecuencia cardíaca y métricas adicionales de bienestar. Un estudio pivotal confirmó lecturas precisas en todos los tonos de piel.
모바노 헬스는 EvieMED 링에 탑재된 맥박 산소 측정기에 대해 FDA 510(k) 승인을 받았으며, 400억 달러 규모의 B2B 헬스케어 시장 기회를 열었습니다. 이 승인은 회사가 임상 시험, 임상 후 관리 및 원격 환자 모니터링 기회를 추구할 수 있도록 합니다. 회사는 이미 2025년 초에 예정된 파일럿 연구를 위한 대규모 지불자와 협의 중이며, 제약 회사 및 CRO와도 논의 중입니다. EvieMED 링은 의료 수준의 정확성과 편안한 착용성을 결합하여 혈액 산소 수준, 심박수 및 추가 웰빙 지표를 측정합니다. 중요한 연구에서 모든 피부 색조에서 정확한 판독 값을 확인했습니다.
Movano Health a reçu l'homologation FDA 510(k) pour le oxymètre de pouls dans son EvieMED Ring, ouvrant ainsi une opportunité de marché B2B dans le secteur de la santé d'une valeur de 40 milliards de dollars. Cette homologation permet à l'entreprise de poursuivre des opportunités dans les essais cliniques, la gestion post-clinique et la surveillance à distance des patients. L'entreprise est déjà en phase d'accord avec un grand payeur pour une étude pilote prévue pour début 2025 et discute avec des entreprises pharmaceutiques et des CRO. L'EvieMED Ring combine une précision de qualité médicale avec un confort de port, mesurant les niveaux d'oxygène dans le sang, le rythme cardiaque et d'autres indicateurs de bien-être. Une étude pivot a confirmé des lectures précises sur tous les teints de peau.
Movano Health hat die FDA 510(k)-Zulassung für den Pulsoximeter im EvieMED Ring erhalten, was eine Marktchance im B2B-Gesundheitswesen im Wert von 40 Milliarden Dollar eröffnet. Die Zulassung ermöglicht es dem Unternehmen, Chancen in klinischen Studien, postklinischer Betreuung und Fernüberwachung von Patienten zu nutzen. Das Unternehmen befindet sich bereits in der Vereinbarungsphase mit einem großen Kostenträger für eine Pilotstudie, die für Anfang 2025 geplant ist, und führt Gespräche mit Pharmaunternehmen und CROs. Der EvieMED Ring kombiniert medizinische Genauigkeit mit komfortablem Tragegefühl und misst den Blut-Sauerstoffgehalt, die Herzfrequenz und weitere Wellness-Metriken. Eine entscheidende Studie bestätigte genaue Messwerte über alle Hauttöne hinweg.
- FDA 510(k) clearance obtained for EvieMED Ring's pulse oximeter
- Access to $40 billion healthcare B2B market opportunity
- Pilot study agreement with large payor planned for early 2025
- Selected for MIT study on long COVID and chronic Lyme disease
- Demonstrated accuracy across all skin tones in pivotal study
- None.
Insights
The FDA 510(k) clearance for EvieMED Ring's pulse oximeter represents a significant milestone for Movano Health, opening access to a
The company's strategic positioning is strengthened by existing partnerships with major healthcare players and planned pilot studies. Key differentiators include accurate readings across diverse skin tones and a comprehensive suite of wellness metrics. The potential for additional FDA clearances for respiration rate monitoring and future development of cuffless blood pressure and noninvasive glucose monitoring capabilities could substantially expand the company's market reach.
For a micro-cap company (
This FDA clearance transforms Movano's business model by enabling entry into lucrative B2B healthcare markets. The immediate pipeline includes
- A pilot study with a major healthcare payor for high-risk population management
- Potential partnerships with a global pharmaceutical company
- Collaboration with a leading CRO for clinical trials
- Participation in MIT's research on long COVID and chronic Lyme disease
The EvieMED Ring's superior compliance potential due to its comfortable design addresses a critical pain point in healthcare monitoring. This competitive advantage, combined with the device's comprehensive data collection capabilities, positions Movano to capture significant market share in the rapidly growing remote patient monitoring sector.
Company's first 510(k) clearance unlocks a TAM of
"We launched the Evie Ring in the consumer wearable market, but our broader goal has always been to provide a clinical-grade device for B2B channels," said John Mastrototaro, President and CEO of Movano Health. "This FDA 510(k) clearance marks a major milestone for the Company and expands our reach to pharmaceutical companies, medical device manufacturers and payors looking for a more accurate, consistent and comfortable health monitoring solution that would help improve compliance by fitting easily into patient lifestyles."
In anticipation of an expected 510(k) clearance, Movano Health has been collaborating with a number of potential partners operating across the entire healthcare industry spectrum and expects its partner pipeline to expand further following the news of a clearance. The Company is currently in the agreement phase with a large payor for a pilot study with the EvieMED Ring planned for early 2025 related to the health management of high-risk populations and is also in discussions with a global pharmaceutical company and leading clinical research organization (CRO) to use the EvieMED Ring in upcoming clinical trials. In addition, the EvieMED Ring was recently selected for a groundbreaking MIT study on long COVID and chronic Lyme disease.
"This milestone marks the beginning of our plans to accelerate distribution of EvieMED. With the significant foundational work in achieving our first clearance now behind us, we are eager to continue to collaborate with the FDA on securing additional clearances including respiration rate and other critical analytes and diagnoses," continued Mastrototaro. "We also remain excited about the opportunities to leverage our proprietary radio frequency (RF) technology to address cuffless blood pressure and noninvasive glucose monitoring."
Pulse oximeters measure blood oxygen (SpO2) levels and heart rate, but conventional solutions have significant shortcomings and can be uncomfortable, discouraging compliance that is needed to ensure reliable information for evaluating a patient's health. The EvieMED Ring eliminates those limitations by combining the accuracy of a medical device with the comfort of a wearable that can be worn continuously, thanks in part to an award-winning design with a small gap in the ring surface and slight flex that accommodates finger swelling. A pivotal study also found that the EvieMED Ring produces accurate readings among users with darker skin tones as measured by the Fitzpatrick scale of skin color classification.
In addition, the EvieMED Ring collects wellness metrics including sleep, activity, temperature variability, calories burned and respiration rate that can give both patients and healthcare providers a broader picture of the user's overall wellness.
The EvieMED Ring will be available in eight sizes ranging from 5 to 12 to accommodate the widest selection of patients.
About Movano Health
Founded in 2018, Movano Inc. (Nasdaq: MOVE) dba Movano Health 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; 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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