Movano Health’s Prototype Chip for Evie Ring Achieves FDA-Recognized Accuracy in Blood Pressure Monitoring Study
10-31-23 (by: Scott Gleason) Movano Health’s prototype wrist-worn device, incorporating its advanced System-on-a-Chip (SoC), demonstrated a level of accuracy in blood pressure monitoring that aligns with the standards recognized by the FDA for medical devices. Movano Health’s SoC, measuring 4 x 6.7 mm, incorporates multiple antennas and a variety of frequencies within the smallest RF-enabled integrated circuit specially designed for blood pressure and glucose monitoring. The chip is planned to be incorporated into the Evie Ring, a wearable smart-technology that Movano Health announced the commercial launch of yesterday. The innovative technology utilizes data from the prototype, coupled with the patient’s demographic information and a recent blood pressure reading, to provide accurate blood pressure measurements.
The prototype displayed an overall mean absolute difference (MAD) of 5.9 mmHg, surpassing the 7 mmHg MAD required for wearable, cuffless blood pressure measuring devices, as required by the industry standard. Movano Health is also exploring the integration of AI-based individual calibration methods to further enhance the device’s performance in the future.
The clinical study involved 44 participants and took place at the Movano Health Clinical Lab. It focused on evaluating the prototype’s accuracy in comparison to a hospital-grade, FDA-cleared blood pressure monitor. The study involved multiple blood pressure measurements for each participant, even during stressful conditions, resulting in an average systolic blood pressure range of 25 mmHg, with a total study range spanning from 85 mmHg to 171 mmHg.
According to Michael Leabman, CTO and founder of Movano Health, the streamlined SoC, combined with enhanced AI algorithms, has generated cleaner signals with reduced noise, expanding the device’s applicability across a broader range of blood pressure values. These findings are pivotal in the company’s quest to bring an FDA-cleared cuffless blood pressure wearable to market.