Movano Health Unveils Evie: First Medical Grade Smart Ring Designed Uniquely for Women

Rhea-AI Summary

Movano Health (Nasdaq: MOVE) plans to file for FDA clearance for its new women-focused wearable, the Evie smart ring, which integrates medical-grade health data into a user-friendly mobile app. Designed to enhance women's health insights, Evie will provide metrics including heart rate, SpO₂, and menstrual tracking, aiming to empower users to make informed health decisions without a subscription fee. Following a successful hypoxia trial confirming accuracy, Evie is set to debut at CES 2023, priced below $300 and available in 2023.

Positive

• Planned FDA clearance for Evie as the first consumer wearable classified as a medical device.
• Successful completion of a hypoxia trial demonstrating regulatory accuracy standards.
• Comprehensive health metrics provided by Evie, enhancing women's health management.
• No monthly subscription fees associated with the Evie smart ring.

Negative

• None.

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.

About Movano Health 

Founded in 2018, Movano Inc. (NASDAQ: MOVE) dba Movano Health is developing a suite of purpose-driven healthcare solutions to bring medical-grade, high-quality data to the forefront of consumer health devices. Featuring modern form factors, Movano Health's devices capture a comprehensive picture of a person's vital health information and uniquely translate the data into personalized and intelligent insights that empower consumers to live healthier and more balanced lives. Movano Health's end-to-end solutions will soon enable consumers, caretakers, and healthcare professionals to utilize daily medical-grade data as a tool to proactively monitor and manage their health. 

Movano Health's Evie Ring, which is specifically designed to address women's health concerns, 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

This press release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially from those anticipated. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding expected future operating results; product development and features, product releases, clinical trial, and regulatory initiatives; our strategies, positioning and expectations for future events or performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission, including under the caption "Risk Factors."  Any forward-looking statement in this release speaks only as of the date of this release. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

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SOURCE Movano

FAQ

What is the Evie smart ring by Movano Health?

The Evie smart ring is a women's health-focused wearable that delivers medical-grade health data and personalized insights via a mobile app.

When will Movano Health seek FDA clearance for Evie?

Movano Health plans to file for FDA clearance for the Evie smart ring following successful testing.

What health data does the Evie smart ring track?

Evie tracks health metrics such as heart rate, SpO₂, menstrual cycles, and overall wellness indicators.

How much will the Evie smart ring cost?

The Evie smart ring is expected to be priced below $300.

When will the Evie smart ring be available for purchase?

The Evie smart ring is anticipated to be available for purchase in mid-2023.