Cuffless blood pressure device starts clinical trials

Cuffless blood pressure device entering trials: ©Freshideas - stock.adobe.com

Movano Health announced that it has started a blood pressure clinical trial with its newly developed cuffless blood pressure wrist wearable. The study, which is expected to include at least 70 participants and be completed this month, utilizes the updated device to monitor pulse pressure waveforms in comparison with a hospital grade blood pressure device. The new wearable will also collect data on other vital signs including pulse rate, blood oxygen saturation, respiration rate, and ECG waveforms.

"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 Movano Health's CTO and Founder Michael Leabman. "I'm excited about the potential the enhanced design offers relative to our previous prototype as it represents a significant leap forward in cuffless blood pressure monitoring."

This study follows three clinical trials that took place in November 2024, June 2024, and October 2023, where the company used its non-invasive devices to collect pulse pressure waveform data from over 60 participants of varying gender, age, ethnicity, and BMI. During each session, participants wore the company’s wrist-worn device along with a hospital-grade FDA-cleared vital signs monitor with cuffed blood pressure measurements or utilizing arterial blood pressure data as the control. In mid-2025, the company plans on executing an additional 100-150 person continuous-blood pressure study using an arterial line, the results of which would help finalize the algorithm expected to be used in a future FDA pivotal trial.

Founded in 2018, Movano Health, maker of the Evie Ring, is developing a suite of purpose-driven health care solutions to bring medical-grade data to the forefront of wearables, according to a company news release. The company aims to 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.