Movano Health's Proprietary Cuffless Blood Pressure Device Once Again Achieves Accuracy Commensurate with the FDA's Requirements
Movano Health (MOVE) announced positive results from an 81-participant blood pressure clinical study for its proprietary cuffless blood pressure device. The wrist-worn prototype achieved a mean absolute difference (MAD) of 4.9 mmHg, surpassing the FDA requirement of 7 mmHg MAD for wearable devices.
The latest prototype features 12 additional mmWave antennas integrated with the company's custom IC, enabling enhanced data collection and a slimmer design. The device can also monitor vital signs including pulse rate, SpO2, respiration rate, and ECG waveforms. The IRB-approved study, conducted at Movano Health Clinical Lab, compared the prototype against a hospital-grade FDA-cleared blood pressure monitor.
With hypertension affecting over 122 million Americans and 59 million having prehypertension, Movano Health is preparing for a pivotal trial to meet FDA clinical requirements, with a consumer-oriented device expected in the coming months.
Movano Health (MOVE) ha annunciato risultati positivi da uno studio clinico sulla pressione sanguigna con 81 partecipanti, riguardante il suo dispositivo proprietario senza bracciale. Il prototipo da polso ha raggiunto una differenza assoluta media (MAD) di 4,9 mmHg, superando il requisito FDA di 7 mmHg MAD per dispositivi indossabili.
L'ultimo prototipo include 12 antenne mmWave aggiuntive integrate con il circuito integrato personalizzato dell'azienda, permettendo una raccolta dati migliorata e un design più sottile. Il dispositivo può anche monitorare segni vitali come frequenza del polso, SpO2, frequenza respiratoria e tracciati ECG. Lo studio approvato dall'IRB, condotto presso il Movano Health Clinical Lab, ha confrontato il prototipo con un monitor della pressione sanguigna di livello ospedaliero approvato dalla FDA.
Con oltre 122 milioni di americani affetti da ipertensione e 59 milioni con preipertensione, Movano Health si sta preparando per una prova cruciale per soddisfare i requisiti clinici FDA, con un dispositivo orientato al consumatore previsto nei prossimi mesi.
Movano Health (MOVE) anunció resultados positivos de un estudio clínico de presión arterial con 81 participantes para su dispositivo exclusivo sin manguito. El prototipo de muñeca logró una diferencia absoluta media (MAD) de 4,9 mmHg, superando el requisito de la FDA de 7 mmHg MAD para dispositivos portátiles.
El último prototipo cuenta con 12 antenas mmWave adicionales integradas con el circuito integrado personalizado de la empresa, lo que permite una mejor recolección de datos y un diseño más delgado. El dispositivo también puede monitorear signos vitales como frecuencia del pulso, SpO2, frecuencia respiratoria y formas de onda ECG. El estudio aprobado por el IRB, realizado en el Laboratorio Clínico de Movano Health, comparó el prototipo con un monitor de presión arterial de grado hospitalario aprobado por la FDA.
Con más de 122 millones de estadounidenses afectados por hipertensión y 59 millones con prehipertensión, Movano Health se prepara para un ensayo crucial para cumplir con los requisitos clínicos de la FDA, con un dispositivo orientado al consumidor previsto para los próximos meses.
Movano Health (MOVE)는 81명의 참가자를 대상으로 한 혈압 임상 연구에서 자사의 독자적인 커프리스 혈압 측정 장치에 대한 긍정적인 결과를 발표했습니다. 손목 착용 프로토타입은 평균 절대 차이(MAD) 4.9 mmHg를 기록하며, 웨어러블 기기에 대한 FDA 요구사항인 7 mmHg MAD를 뛰어넘었습니다.
최신 프로토타입은 회사의 맞춤형 IC와 통합된 12개의 추가 mmWave 안테나를 특징으로 하여 데이터 수집을 향상시키고 더 슬림한 디자인을 가능하게 했습니다. 이 장치는 맥박수, 산소포화도(SpO2), 호흡수, 심전도(ECG) 파형 등 생체 신호도 모니터링할 수 있습니다. IRB 승인을 받은 이번 연구는 Movano Health 임상 연구소에서 진행되었으며, 프로토타입을 FDA 승인 병원급 혈압 모니터와 비교했습니다.
1억 2,200만 명 이상의 미국인이 고혈압을 앓고 있고 5,900만 명이 전단계 고혈압 상태인 가운데, Movano Health는 FDA 임상 요구사항을 충족하기 위한 중대한 시험을 준비 중이며, 소비자용 장치는 향후 몇 달 내 출시될 예정입니다.
Movano Health (MOVE) a annoncé des résultats positifs issus d'une étude clinique sur la pression artérielle impliquant 81 participants pour son dispositif propriétaire sans brassard. Le prototype porté au poignet a atteint une différence absolue moyenne (MAD) de 4,9 mmHg, dépassant l'exigence de la FDA de 7 mmHg MAD pour les dispositifs portables.
Le dernier prototype intègre 12 antennes mmWave supplémentaires avec la puce personnalisée de l'entreprise, permettant une collecte de données améliorée et un design plus fin. L'appareil peut également surveiller les signes vitaux tels que la fréquence du pouls, la SpO2, la fréquence respiratoire et les formes d'onde ECG. L'étude approuvée par l'IRB, menée au laboratoire clinique de Movano Health, a comparé le prototype à un moniteur de pression artérielle de qualité hospitalière approuvé par la FDA.
Avec plus de 122 millions d'Américains souffrant d'hypertension et 59 millions en préhypertension, Movano Health se prépare à un essai pivot pour répondre aux exigences cliniques de la FDA, avec un dispositif destiné aux consommateurs attendu dans les prochains mois.
Movano Health (MOVE) gab positive Ergebnisse einer klinischen Blutdruckstudie mit 81 Teilnehmern für sein proprietäres blutdruckmessendes Gerät ohne Manschette bekannt. Der am Handgelenk getragene Prototyp erreichte eine mittlere absolute Differenz (MAD) von 4,9 mmHg und übertraf damit die FDA-Anforderung von 7 mmHg MAD für tragbare Geräte.
Der neueste Prototyp verfügt über 12 zusätzliche mmWave-Antennen, die in den firmeneigenen IC integriert sind, was eine verbesserte Datenerfassung und ein schlankeres Design ermöglicht. Das Gerät kann auch Vitalzeichen wie Pulsfrequenz, SpO2, Atemfrequenz und EKG-Wellenformen überwachen. Die vom IRB genehmigte Studie, die im Movano Health Clinical Lab durchgeführt wurde, verglich den Prototyp mit einem von der FDA zugelassenen Blutdruckmessgerät in Krankenhausqualität.
Da über 122 Millionen Amerikaner an Bluthochdruck leiden und 59 Millionen an Prä-Hypertonie, bereitet sich Movano Health auf eine entscheidende Studie vor, um die klinischen Anforderungen der FDA zu erfüllen. Ein verbraucherorientiertes Gerät wird in den kommenden Monaten erwartet.
- Clinical study exceeded FDA accuracy requirements with 4.9 mmHg MAD vs 7 mmHg threshold
- Enhanced prototype features improved data collection and slimmer design
- Device monitors multiple vital signs beyond blood pressure
- Technology demonstrates improved sensitivity and signal reliability
- Company advancing toward FDA pivotal trial
- Product still requires FDA clearance before commercialization
- Additional clinical trials needed before regulatory submission
Insights
Movano's blood pressure wearable achieves FDA-level accuracy using proprietary RF technology, positioning it to address the massive hypertension market.
Movano Health's latest clinical study results demonstrate significant technical progress for their cuffless blood pressure monitoring technology. Their wrist-worn prototype achieved a mean absolute difference of 4.9 mmHg, substantially better than the 7 mmHg threshold required by standards recognized by the FDA (IEEE1708a-2019) for such devices.
The 81-participant study showcases several important technical advancements. The integration of 12 additional mmWave antennas with their custom System-on-a-Chip has yielded improved signal quality with reduced placement sensitivity - a critical factor for wearable devices. This RF-based approach represents a departure from traditional cuff-based measurements, potentially enabling continuous monitoring rather than isolated readings.
What's particularly noteworthy is the device's multi-parameter capabilities. Beyond blood pressure, it can monitor pulse rate, SpO2, respiration rate, and ECG waveforms - suggesting a comprehensive health monitoring platform. The study included measurements under stress conditions, indicating the technology works across various physiological states.
The clinical context is significant: hypertension affects over 122 million Americans with another 59 million having prehypertension. Continuous blood pressure monitoring represents a substantial unmet need in both consumer and clinical markets.
However, regulatory hurdles remain. While these results exceed accuracy requirements, the company is still planning a pivotal trial to satisfy FDA clinical requirements. This represents a critical step before potential clearance and commercialization. The mention of a "consumer-oriented device just a few months away" suggests they're making progress toward productization, though FDA clearance would likely follow the pivotal trial.
Positive clinical results advance Movano toward commercializing a potentially groundbreaking cuffless BP monitor for an enormous untapped market.
Movano Health's clinical study results represent a significant milestone in their product development roadmap. The company has successfully demonstrated that their proprietary blood pressure monitoring technology can achieve accuracy levels exceeding regulatory requirements, a crucial technical validation for medical device commercialization.
What makes this development particularly noteworthy is the substantial addressable market. Hypertension affects half of Americans ages 20 and older - over 122 million people according to the American Heart Association data cited. This creates a massive potential market for continuous blood pressure monitoring technology that doesn't require traditional cuffs.
The company's technological approach offers key advantages. Their custom IC (integrated circuit) and RF-based sensing technology enables a wrist-worn form factor that can simultaneously track multiple vital signs. This positions their solution as potentially more comfortable and convenient than traditional monitoring methods while providing more continuous data.
From a development perspective, Movano appears to be making steady progress through their product roadmap. Their current prototype incorporates their custom System-on-a-Chip, suggesting they've advanced from concept to working technology. The mention of a "more consumer-oriented device just a few months away" indicates they're approaching the next phase of development.
However, investors should note that regulatory approval timelines remain uncertain. The company is "in the planning stage of a pivotal trial to satisfy FDA clinical requirements," indicating several steps remain before potential commercialization. While this clinical validation is positive, the path to revenue generation still involves regulatory approval, manufacturing scale-up, and market penetration challenges.
Leveraging the Company's System-on-a-Chip (SoC), the clinical study results are another significant step forward in commercializing a cuffless, radio frequency (RF)-enabled blood pressure device
Hypertension has reached epidemic proportions in
This most recent study incorporated the latest version of the Company's wrist-worn wearable prototype, featuring an additional 12 mmWave antennas. When combined together with the Company's custom IC, the wearable delivers enhanced data collection with less impact of placement while also featuring a slimmer design, making it easier and more comfortable to wear. In addition, the new wearable can monitor a host of other vital signs including pulse rate, blood oxygen saturation (SpO2), respiration rate and ECG waveforms. The increased number of RF antennas, as well as the addition of new signals for enhanced sensor fusion, has facilitated a marked increase in sensitivity and signal reliability from the Company's previous design, resulting in an even higher level of accuracy than the prior study, and represents a significant leap forward in cuffless blood pressure monitoring. With a more consumer-oriented device just a few months away, Movano Health is currently in the planning stage of a pivotal trial to satisfy FDA clinical requirements.
The IRB-approved study was conducted at the Movano Health Clinical Lab and assessed the accuracy of the Company's wrist-worn prototype compared to a hospital-grade FDA-cleared blood pressure monitor. The study measured the blood pressure of each participant multiple times, including while under stress.
"After multiple iterations of optimizing our IC, antennas, and AI algorithms, our SoC produced much cleaner signals with significantly less noise in this study than our multiple chip solution did previously," said Michael Leabman, CTO and founder of Movano Health. "Most importantly, we learned that our machine learning models hold across a broader range of blood pressure values than in prior studies, which is crucial for our pursuit of commercializing an FDA cleared cuffless blood pressure wearable."
"Our goal is to deliver a more accurate, flexible and cost-effective wearable blood pressure solution, and this study reveals the initial payoff of our investment in proprietary mmWave sensor technology. We are extremely encouraged with the performance of our SoC and look forward to the next step of confirming the platform in pivotal studies, which would open a pathway to regulatory filings," said John Mastrototaro, CEO of Movano Health.
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 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/.
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