Company plans to file for FDA clearance of a new wearable that provides women with medical grade data and personalized actionable insights to track and manage overall health
PLEASANTON, Calif., Dec. 28, 2022 /PRNewswire/ — Movano Health (Nasdaq: MOVE), a purpose-driven healthcare solutions company at the intersection of medical and consumer devices, today announces its smart ring, Evie. Designed specifically for women, Evie is sleek, intelligent, and comfortable, providing users with medical grade health data that’s translated into personalized insights delivered through a mobile app, with no monthly subscription.
Movano Health is planning to seek FDA clearance for Evie, which will make it the first consumer wearable that is also a medical device. The Company plans to file for pulse oximetry metrics after having completed a successful hypoxia trial in October 2022, where accuracy for clinical SpO2 and heart rate commensurate with FDA’s consensus standard was demonstrated. While a few wearables are only FDA cleared for specific software, such as ECG and Afib, Evie is designed per regulatory standards and built in a medical device manufacturing facility that meets ISO13485 and cGMP standards. The clearance will offer women trusted and personalized insights that can help them draw connections between cause and effect, so they can better understand the “why” behind what they’re feeling. Additionally, Evie will deliver data that clinicians can deem reliable for patient care.
Evie combines health and wellness metrics to give a full picture of one’s health: resting heart rate, heart rate variability, SpO2, respiration rate, skin temperature variability, period and ovulation tracking, menstrual symptom tracking, activity profile, including steps, active minutes and, calories burned, sleep stages and duration, and mood tracking. This data is delivered through a mobile app which aims to simplify how data is presented, moving away from complex graphs and charts, and turning biometric data into actionable insights that will help women make manageable lifestyle changes and take a more proactive approach to mitigating the risks of chronic disease. For example, Evie uses medical grade heart rate and SpO2 data to help identify patterns in her sleep quality and trends in her menstrual cycle, so she can understand her body’s natural baseline and over time learn how to feel her best. Because a successful day looks different for every woman, the solution places as much emphasis on recovery as it does activity and encourages women to set goals related to both physical and mental health.
“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.”
Evie will be unveiled during CES 2023 alongside a demo showcasing its features and allowing consumers to gather live heart rate and SpO2 level readings within the app. It is made of polished aluminum and will come in three different finishes. The ring will be available in sizes 5-11, and its open design allows for a comfortable fit. The smart ring is expected to cost under $300 with no added monthly subscription fees and will be available in 2023.
For more information about the Evie Ring, visit EvieRing.com.