Movano Health's Proprietary Cuffless Blood Pressure Device Once Again Achieves Accuracy Commensurate with the FDA's Requirements

Rhea-AI Summary

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.

Positive

• 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

Negative

• Product still requires FDA clearance before commercialization
• Additional clinical trials needed before regulatory submission

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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

PLEASANTON, Calif., April 22, 2025 /PRNewswire/ -- Movano Health (Nasdaq: MOVE), a pioneer in health technology, today announced positive results of its most recent 81-participant blood pressure clinical study. Movano Health's prototype demonstrated a level of accuracy well within the standards recognized by the FDA for blood pressure monitoring devices, achieving an overall mean absolute difference (MAD) of 4.9 mmHg, which significantly exceeds the 7 mmHg MAD threshold required per a standard for wearable, cuffless blood pressure measuring devices (IEEE1708a-2019).

Hypertension has reached epidemic proportions in the United States and is often labeled the silent killer as many don't know they are affected. According to the American Heart Association, high blood pressure affects half of Americans ages 20 years and older – or more than 122 million people – and 59 million Americans have prehypertension, making longitudinal blood pressure monitoring arguably the next frontier in continuous monitoring and the single most important clinical metric. Movano Health's cutting-edge RF technology has the potential to empower individuals and their clinicians to better monitor and manage high blood pressure on a daily basis.

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/.  

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 and addressable markets; planned cost-cutting initiatives; anticipated FDA clearance decisions with respect to our products; expected future operating results; product development efforts and product releases; clinical trial and regulatory initiatives; commercial partner activities; 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

FAQ

What accuracy did Movano Health's (MOVE) blood pressure device achieve in clinical trials?

The device achieved a mean absolute difference (MAD) of 4.9 mmHg, significantly better than the 7 mmHg MAD threshold required by FDA standards for wearable, cuffless blood pressure devices.

What features does Movano Health's (MOVE) new blood pressure wearable include?

The wrist-worn device includes 12 mmWave antennas, custom IC, and monitors blood pressure, pulse rate, blood oxygen saturation, respiration rate, and ECG waveforms.

When will Movano Health (MOVE) launch its consumer blood pressure device?

A consumer-oriented device is expected in a few months, pending completion of a pivotal trial to satisfy FDA clinical requirements.

How many participants were in Movano Health's (MOVE) latest blood pressure study?

The clinical study included 81 participants and was conducted at the Movano Health Clinical Lab.

What is the market potential for Movano Health's (MOVE) blood pressure device?

The device targets a significant market with over 122 million Americans affected by high blood pressure and 59 million with prehypertension.