Movano Health Announces Completion of Clinical Study with Cuffless RF Blood Pressure Device
Movano Health (Nasdaq: MOVE) has completed testing of its new blood pressure wrist wearable during a hypoxia clinical trial at UC San Francisco. The enhanced device features 12 additional mmWave antennas and a custom IC, delivering improved data collection with a slimmer, more comfortable design. The wearable also monitors vital signs including pulse rate, blood oxygen saturation, respiration rate, and ECG waveforms.
This study follows two clinical trials from October 2023 and June 2024, where the company's non-invasive device collected pulse pressure waveforms data from over 50 participants. The device improvements were implemented based on learnings from these previous studies to achieve higher fidelity blood pressure signals.
Movano Health (Nasdaq: MOVE) ha completato i test del suo nuovo dispositivo indossabile da polso per la pressione sanguigna durante uno studio clinico di ipossia presso l'UC San Francisco. Il dispositivo migliorato è dotato di 12 antenne mmWave aggiuntive e di un circuito integrato personalizzato, offrendo una raccolta dati migliorata con un design più sottile e confortevole. Il dispositivo indossabile monitora anche i segni vitali, inclusi il battito cardiaco, la saturazione di ossigeno nel sangue, la frequenza respiratoria e le forme d'onda ECG.
Questo studio segue due studi clinici realizzati nell'ottobre 2023 e nel giugno 2024, durante i quali il dispositivo non invasivo dell'azienda ha raccolto dati sulle forme d'onda della pressione del polso da oltre 50 partecipanti. I miglioramenti del dispositivo sono stati implementati sulla base delle informazioni ottenute da questi studi precedenti per ottenere segnali di pressione sanguigna di maggiore fedeltà.
Movano Health (Nasdaq: MOVE) ha completado las pruebas de su nuevo dispositivo portátil para medir la presión arterial en la muñeca durante un ensayo clínico de hipoxia en UC San Francisco. El dispositivo mejorado cuenta con 12 antenas mmWave adicionales y un circuito integrado personalizado, lo que permite una recolección de datos mejorada con un diseño más delgado y cómodo. El dispositivo portátil también monitorea los signos vitales, incluidos la frecuencia del pulso, la saturación de oxígeno en sangre, la frecuencia respiratoria y las formas de onda del ECG.
Este estudio sigue a dos ensayos clínicos realizados en octubre de 2023 y junio de 2024, en los cuales el dispositivo no invasivo de la empresa recogió datos sobre las formas de onda de la presión del pulso de más de 50 participantes. Las mejoras del dispositivo se implementaron con base en los aprendizajes de estos estudios previos para lograr señales de presión arterial de mayor fidelidad.
모바노 헬스(MNASDAQ: MOVE)는 샌프란시스코 캘리포니아대학에서 실시된 저산소증 임상 시험 동안 새로운 혈압 손목 착용 기기의 테스트를 완료했습니다. 개선된 장치는 12개의 mmWave 안테나와 맞춤형 IC를 특징으로 하여, 더욱 얇고 편안한 디자인으로 향상된 데이터 수집을 제공합니다. 이 착용 기기는 또한 생체 신호를 모니터링하여 심박수, 혈중 산소 포화도, 호흡 수, ECG 파형 등을 포함합니다.
이번 연구는 2023년 10월과 2024년 6월에는 실시된 두 개의 임상 시험에 이어 진행되며, 이 회사의 비침습적 장치가 50명 이상의 참가자로부터 맥압 파형 데이터를 수집했습니다. 장치 개선 사항은 이전 연구에서 얻은 교훈을 바탕으로 시행되어 보다 높은 충실도의 혈압 신호를 달성하게 되었습니다.
Movano Health (Nasdaq: MOVE) a terminé les tests de son nouveau dispositif portable au poignet pour la mesure de la pression artérielle lors d'un essai clinique d'hypoxie à l'UC San Francisco. Le dispositif amélioré est doté de 12 antennes mmWave supplémentaires et d'un circuit intégré personnalisé, offrant une collecte de données améliorée avec un design plus fin et plus confortable. Le dispositif portable surveille également les signes vitaux, notamment le rythme cardiaque, la saturation en oxygène dans le sang, la fréquence respiratoire et les formes d'onde ECG.
Cette étude fait suite à deux essais cliniques réalisés en octobre 2023 et en juin 2024, au cours desquels le dispositif non invasif de l'entreprise a recueilli des données sur les formes d'onde de la pression du pouls de plus de 50 participants. Les améliorations du dispositif ont été mises en œuvre sur la base des enseignements tirés de ces études précédentes afin d'obtenir des signaux de pression artérielle de plus haute fidélité.
Movano Health (Nasdaq: MOVE) hat die Tests seines neuen tragbaren Handgelenkgeräts zur Blutdruckmessung während einer Hypoxie-Studie an der UC San Francisco abgeschlossen. Das verbesserte Gerät verfügt über 12 zusätzliche mmWave-Antennen und einen benutzerdefinierten IC, der eine verbesserte Datenerfassung mit einem schlankeren, bequemeren Design bietet. Das tragbare Gerät überwacht auch Vitalzeichen, einschließlich Pulsfrequenz, Blut-Sauerstoffsättigung, Atemfrequenz und ECG-Wellenformen.
Diese Studie folgt auf zwei klinische Studien aus Oktober 2023 und Juni 2024, in denen das nicht-invasive Gerät des Unternehmens Pulsdruckwellen-Daten von über 50 Teilnehmern gesammelt hat. Die Verbesserungen des Geräts wurden auf Basis der Erkenntnisse aus diesen vorherigen Studien implementiert, um eine höhere Signaltreue bei der Blutdruckmessung zu erreichen.
- Enhanced device features with 12 additional mmWave antennas for improved data collection
- Slimmer and more comfortable design achieved
- Expanded functionality to monitor multiple vital signs
- Successfully completed multiple clinical trials with diverse participant groups
- None.
Insights
The development of Movano Health's enhanced blood pressure wearable represents a significant technical advancement in non-invasive monitoring. The addition of 12 mmWave antennas and custom IC integration addresses key challenges in cuffless BP measurement - signal quality and placement sensitivity. The device's multi-parameter monitoring capabilities (BP, SpO2, ECG, respiration) position it competitively in the growing remote patient monitoring market.
The iterative clinical validation approach, with studies involving over 50 diverse participants and comparison against hospital-grade equipment, demonstrates a methodical path toward potential FDA clearance. However, while technical improvements are promising, the company needs to demonstrate clinical accuracy meeting regulatory standards and publish comprehensive validation data before commercial viability can be assessed.
New hardware boasts significant improvements to reduce noise and generate higher fidelity signals
"Our redesigned device is the culmination of months of testing and refinement, and we are very excited to be able to put it to the test in the clinical lab," said Movano Health's CTO and Founder Michael Leabman. "The increased number of RF antennas, as well as the addition of new signals for enhanced sensor fusion, has resulted in a marked increase in sensitivity and signal reliability from our previous design and represents a significant leap forward in cuffless blood pressure monitoring."
This study follows two clinical trials that took place in October 2023 and June 2024 where the Company used its non-invasive device to collect pulse pressure waveforms data from over 50 participants of varying gender, age, ethnicity and BMI. During each session, participants wore Movano Health's wrist-worn device along with a hospital-grade FDA-cleared vital signs monitor with cuffed blood pressure measurements or utilized arterial blood pressure data as the control. Learnings from these two studies prompted device enhancements designed to deliver higher fidelity blood pressure signals and ensure successful clinical results.
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.
UC Disclaimer
The information stated above was prepared by Movano Health and reflects solely the opinion of the corporation. Nothing in this statement shall be construed to imply any support or endorsement of Movano Health, or any of its products, by The Regents of the University of
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FAQ
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