The company plans to apply for FDA approval of a new wearable device that provides women with medical-grade data and personalized actionable insights to track and manage overall health.
PLEASANTON, Calif., December 28, 2022 /PRNewswire/ — Movano Health (Nasdaq: MOVE), a purpose-driven healthcare solutions company at the intersection of consumer and medical devices, today announces its smart ring, evie. Designed specifically for women, Evie is stylish, smart and comfortable, providing users with medical-grade health data that is translated into personalized insights through a mobile app – with no monthly subscription.
Evie Ring Renderings – The first medical grade smart ring designed exclusively for women.
Movano Health plans to seek FDA approval for Evie, making it the first consumer wearable device that is also a medical device. The Company plans to request pulse oximetry metrics after successfully completing a hypoxia test at October 2022where the accuracy of the clinical SpO2 and a heart rate consistent with the FDA consensus standard was demonstrated. While some handheld devices only have FDA approval for specific software, such as ECG and Afib, Evie is designed to regulatory standards and is integrated into an ISO13485 and cGMP compliant medical device manufacturing facility. Empowerment will offer women trusted and personalized insights that can help them make connections between cause and effect, so they can better understand the “why” behind what they feel. Additionally, Evie will provide data that clinicians may consider reliable for patient care.
Evie combines health and wellness metrics to provide a complete picture of 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 via a mobile app that aims to simplify the way data is presented, moving away from complex graphs and charts, and turning biometric data into actionable information that will help women make lifestyle changes. manageable lives and take a more proactive approach to mitigating risks. of chronic disease. For example, Evie uses medical grade heart rate and SpO2 data to help identify patterns in your sleep quality and trends in your menstrual cycle, so you can understand your body’s natural baseline and, over time, learn to feel better. Because a successful day is different for every woman, The Solution places as much emphasis on recovery as it does on activity and encourages women to set goals related to physical and mental health.
“As a medical device, Evie will go beyond the status quo of other wearable devices on the market, and we believe it has the power to transform women’s lives and overall health,” said Dr. Juan Mastrototaro, CEO of Movano Health. “We are bringing together medical-grade biometric data and information into a comfortable, contemporary wearable device that empowers women to take charge of their unique healthcare journey.”
Evie will be unveiled during CES 2023 along with a demo showcasing its features and allowing consumers to collect live SpO2 and heart rate.2 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 less $300 with no additional monthly subscription fees and will be available in 2023.
For more information on the Evie ring, visit EvieRing.com.
About Movano Health
Founded in 2018, Movano Inc. (NASDAQ: MOVE) dba Movano Health is developing a suite of purpose-built healthcare solutions to bring high-quality, medical-grade data to the forefront of consumer healthcare devices. With modern form factors, Movano Health devices capture a complete picture of a person’s vital health information and uniquely translate the data into intelligent, personalized information that empowers consumers to live healthier, more balanced lives. Movano Health’s comprehensive solutions will soon enable consumers, caregivers and healthcare professionals to use daily medical-grade data as a tool to proactively monitor and manage their health.
Designed specifically to address women’s health concerns, Movano Health’s Evie Ring will debut at CES 2023 and will be available for purchase in mid-2023. For more information on Movano Health, visit www.movanohealth.com.
forward-looking statements
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SOURCE Movano
