Study Demonstrates Accuracy of Movano’s Cuffless Blood Pressure Prototype

Movano Health is sharing results of its Institutional Review Board (IRB)-approved blood pressure clinical study. The company’s prototype, which incorporated its SoC, demonstrated a level of accuracy within the standards recognized by the U.S. Food and Drug Administration (FDA) for blood pressure monitoring devices. Movano Health’s algorithm for blood pressure monitoring used data from its prototype system combined with the subject’s demographic information and a recent blood pressure reading. 
 
The prototype achieved a 5.9 mmHg overall mean absolute difference (MAD)—below the 7 mmHg MAD required for wearable, cuffless blood pressure measuring devices (IEEE1708a-2019). The company is also evaluating artificial intelligence-based individual calibration methods to further enhance the device’s future performance. The 44-participant study, conducted at the Movano Health Clinical Lab, assessed the accuracy of its wrist-worn wearable 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, which resulted in 25 mmHg average participant systolic blood pressure range and an 85 mmHg- 171 mmHg total study range.
 
The company’s 4 mm x 6.7 mm SoC combines multiple antennas and various frequencies in the smallest ever RF-enabled integrated circuit designed specifically for blood pressure and glucose monitoring. After shrinking its multi-chip architecture from four chips into one in mid-2022, Movano Health began using the patented SoC in clinical studies last year, that latest chip architecture has materially improved the accuracy of its blood pressure measurements as evidence by the study results. In its current form factor, Movano Health’s wearable prototype represents one of the smallest and most accessible ways to measure blood pressure.
 
“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,” Movano Health Founder/Chief Technology Officer Michael Leabman said. “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.”
 
Hypertension has reached epidemic proportions in the United States and is considered the “silent killer” since many people are not aware they are affected. According to American Heart Association data, high blood pressure affects half of Americans ages 20 years and older—more than 122 million people—and 59 million Americans have prehypertension. Movano Health’s RF technology can potentially empower individuals and their clinicians to better monitor and manage their high blood pressure on a daily basis.
 
“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 propriety mmWave sensor technology. We are extremely encouraged with the performance of our SoC, and the next step is to confirm the calibration holds in longer studies, which would open a pathway to implementing the SoC in future iterations of the Evie Ring and other form factors,” Movano Health CEO John Mastrototaro stated.
 
Movano Health is conducting a multi-week longitudinal study to determine whether periodic calibration is required and refine its AI models on an individual patient basis. Once the analysis is completed, the company intends to conduct a clinical trial for its 510(k) submission to the FDA. 
 
Founded in 2018, Movano Health is developing a suite of purpose-driven healthcare solutions to bring medical-grade, high-quality data to the forefront of consumer health devices. Featuring modern form factors, Movano Health’s devices capture a comprehensive picture of a person’s vital health information and translate the data into personalized and intelligent insights that empower consumers to live healthier and more balanced lives. Movano Health’s end-to-end solutions will soon enable consumers and their healthcare professionals to utilize daily medical-grade data as a tool to proactively monitor and manage health outcomes.