Pleasanton, California-based Movano designed Evie to offer intelligence and comfortability in a sleek appearance. It provides users with medical-grade health data for translation into personalized insights delivered through a mobile app.
The system requires no monthly subscription, according to a news release.
Movano plans to seek FDA clearance for Evie. It plans to file for pulse oximetry metrics after completing a hypoxia trial in October 2022. That trial demonstrated accuracy for clinical SpO2 and heart rate that came in commensurate with FDA standards.
The company said clearance would make it the first consumer wearable to double as a medical device. Wearables already exist with FDA clearance for software that detects ECG and AFib, among other things. However, Movano said Evie features a regulatory-standard design. It built the system in a manufacturing facility that meets ISO13485 and cGMP standards.
What Movano says Evie can offer
Evie could provide women with personalized insights to help draw connections between cause and effect. It also provides data for clinicians to deem reliable for patient care, Movano said.
The system offers metrics for resting heart rate variability, SpO2, respiration rate and skin temperature variability. It aids in period and ovulation tracking, menstrual symptom tracking, activity profile, sleep tracking and mood tracking. Evie delivers data through a mobile app to help women make manageable lifestyle changes and take a proactive approach to mitigating risks of chronic disease.
“As a medical device, Evie will go beyond the status quo of other wearables on the market, and we believe it has the power to transform women’s lives and overall health,” said Dr. John Mastrototaro, CEO of Movano Health. “We are bringing together medical-grade biometric data and insights in a comfortable and contemporary wearable that allows women to take ownership of their unique health journey.”
Movano plans to unveil Evie during CES 2023. It constructed the system with polished aluminum and plans to offer it in three different finishes. The ring comes in sizes 5-11 for a comfortable fit. Movano intends to charge under $300 for the smart ring with no added monthly subscription fees. It plans for availability in 2023.