Movano Health has commenced a clinical trial to evaluate its newly developed cuffless blood pressure wrist wearable, marking a significant step toward more convenient and accessible blood pressure monitoring. The study, initiated in February 2025, aims to refine the device's ability to accurately measure pulse pressure waveforms compared to traditional hospital-grade blood pressure devices.
The trial, involving at least 70 participants, is designed to assess the updated wearable's performance in real-world conditions. In addition to blood pressure, the device collects data on other vital signs, including pulse rate, blood oxygen saturation (SpO2), respiration rate, and ECG waveforms, offering a comprehensive view of the user's physiological state.
Enhanced Design for Higher Fidelity Data
Michael Leabman, CTO and Founder of Movano Health, emphasized the improvements incorporated into the new device. "We have learned a great deal since our last clinical trial in November 2024 and have refined the use of our proprietary cuffless blood pressure wearable in order to extract higher fidelity data," said Leabman. He expressed enthusiasm about the enhanced design, noting it represents a significant leap forward in cuffless blood pressure monitoring.
The current study builds upon three previous clinical trials conducted in October 2023, June 2024 and November 2024. These earlier trials involved over 60 participants with diverse characteristics, including varying gender, age, ethnicity, and BMI. During these sessions, participants wore Movano Health's wrist-worn device alongside a hospital-grade, FDA-cleared vital signs monitor with cuffed blood pressure measurements or arterial blood pressure data as a control.
Future Studies and FDA Plans
Movano Health plans to conduct a larger, 100-150 person continuous blood pressure study in mid-2025, utilizing an arterial line for data collection. The results from this study are expected to finalize the algorithm that will be used in a future FDA pivotal trial, bringing the company closer to regulatory approval and commercialization of its cuffless blood pressure monitoring technology.
About Movano Health
Founded in 2018, Movano Health is focused on developing healthcare solutions that bring medical-grade data to wearable technology. The company's Evie Ring and other devices aim to provide users and enterprises with trusted health data, translated into personalized and intelligent insights.
