Movano Health’s cuffless wearable blood pressure monitor: A game-changer in health technology

Movano Health is on track to deliver one of the most promising solutions in wearable health technology, a cuffless, wrist-worn blood pressure monitor that meets the accuracy standards of the U.S. Food and Drug Administration (FDA). With cardiovascular disease remaining the leading cause of death worldwide, innovations like this could offer new tools for early detection and ongoing health management, especially for the millions living with hypertension and prehypertension.

Medical-grade accuracy in a consumer device

In a clinical study involving 81 participants, Movano Health’s latest prototype achieved a mean absolute difference (MAD) of 4.9 mmHg, significantly better than the FDA’s benchmark of 7 mmHg for wearable blood pressure devices. The study was conducted at the company’s IRB-approved clinical lab, using an FDA-cleared hospital-grade monitor as the reference device.

These results reflect a major technical milestone. While other consumer wearables have attempted to integrate blood pressure monitoring, many fall short of regulatory accuracy standards. Movano’s device, however, was designed with a strong clinical foundation in mind.

The device integrates 12 mmWave antennas and a custom system-on-chip (SoC) to capture health data. These components allow for better signal collection, improved accuracy, and a slimmer, more ergonomic design—key considerations for users who might wear the device all day.

Broader health tracking capabilities

In addition to monitoring blood pressure, the prototype is equipped to track several other essential health indicators. These include pulse rate, blood oxygen saturation (SpO₂), respiration rate, and ECG waveforms. By capturing a broader range of vital signs, the device provides users and healthcare providers with a more comprehensive view of overall cardiovascular and respiratory health.

This multi-metric approach enhances the device’s clinical utility, offering a comprehensive view of cardiovascular and respiratory health. Instead of relying on multiple wearables, users can monitor their vital signs from one device, potentially increasing adherence and improving long-term health outcomes.

Addressing a widespread public health issue

Hypertension affects over 122 million American adults, with an additional 59 million in the prehypertensive range. Unfortunately, many remain undiagnosed due to the infrequency and inconvenience of traditional monitoring methods.

Blood pressure is typically checked during doctor visits, which may miss daily fluctuations or early signs of disease. Continuous, real-time monitoring with a comfortable, cuffless device can address this gap. For those already diagnosed, consistent tracking helps guide lifestyle changes and medication adjustments. For at-risk individuals, the device could enable early detection before complications develop.

Designed for daily use

Traditional blood pressure cuffs, especially automated home units, can be bulky and difficult for some people to use correctly. Movano’s wrist-worn device removes that barrier. By streamlining the user experience, the device becomes something people are more likely to wear consistently, yielding richer and more actionable health data.

The lightweight form factor and discrete design aim to encourage long-term use without disrupting the user’s routine. A cuffless system is not only more convenient but also less likely to cause user anxiety, something that can artificially raise blood pressure during measurements.

On the path to FDA clearance

While early results are promising, full regulatory approval requires more than one trial. Pivotal clinical studies will test the device across varied conditions, including different age groups, skin tones, body types, and activity levels—key factors in wearable tech accuracy.

CEO John Mastrototaro stated that the results confirm years of investment in proprietary mmWave technology, expressing optimism about the platform’s future in pivotal trials. CTO Michael Leabman highlighted the improvements made to enhance signal clarity and reduce noise, particularly during movement, adding that the system’s machine learning models performed well across a broader range of blood pressure values.

Pending trial success, a consumer version could launch within months, intended for use at home, in clinics, and for remote monitoring, bridging personal wellness and clinical care.

Opportunities in remote and preventive care

As healthcare shifts toward preventive care and remote monitoring, Movano’s technology aligns with broader industry trends. Wearable health devices are no longer just fitness trackers; they’re evolving into clinical-grade tools that can help detect and manage chronic diseases.

Doctors and patients alike are turning to technology to stay ahead of health concerns, especially when regular in-person visits aren’t feasible. This shift was accelerated during the COVID-19 pandemic, but the long-term benefits of remote monitoring are now widely recognized.

Wearables that meet clinical standards are especially valuable for programs targeting high-risk patients, such as those with heart disease, diabetes, or respiratory illness. Movano’s device, with its ability to track multiple vital signs, could become a key part of integrated care models.

From data to insight

One of the most powerful aspects of this device is not just the data it collects, but how that data can be used. Leveraging machine learning, Movano Health aims to turn raw sensor readings into actionable health insights.

For example, the device could notify users or clinicians when readings fall outside normal ranges, prompting early intervention. This could prevent emergency visits, reduce healthcare costs, and help patients better understand their own health.

This aligns closely with the growing field of Wearable Health Devices – Impact on Patient Health, which highlights how such tools are reshaping care delivery, patient engagement, and chronic disease management on a global scale.

Challenges and considerations

Despite its promise, the success of Movano’s cuffless device will depend on several factors beyond clinical accuracy.

First, it must gain FDA clearance and demonstrate long-term reliability in real-world settings. Clinical success doesn’t always guarantee consumer adoption. The company must also ensure that the user interface is intuitive and that data privacy protections meet industry standards.

Additionally, pricing and accessibility will play a role in how widely the device is adopted. A device that offers clinical accuracy but is priced out of reach for average users would fail to realize its full impact.

Fortunately, Movano Health appears to be positioning its product as both a medical tool and a consumer-friendly wearable, which could help it stand out in a crowded market of fitness and health trackers.

A promising step toward smarter health monitoring

With strong early clinical results and a user-centered design, Movano Health’s cuffless blood pressure monitor could transform how people engage with their health.Its capacity to monitor various vital signs with FDA-approved accuracy, directly from the wrist, brings us nearer to a future where real-time, personalized health insights are seamlessly integrated into everyday life.

As the company prepares for pivotal trials and potential market entry, its prototype stands at the intersection of clinical science and wearable convenience, offering a meaningful step toward smarter, more accessible health monitoring for all.