Evie Ring's Pulse Oximeter Exceeds FDA Accuracy Guidelines in Movano Health's Second Hypoxia Trial
- Movano Health's Evie Ring pulse oximeter exceeded FDA guidelines in the recent hypoxia trial with UCSF, showcasing its accuracy.
- The Evie Ring's clinical performance was a key focus for Movano Health's FDA submission, with plans to address outstanding comments and present new data in April 2024.
- The Evie Ring offers a wide range of health and wellness metrics through a mobile app, aiming to simplify data presentation and empower users to make informed health decisions.
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Insights
The recent announcement by Movano Health regarding their Evie Ring pulse oximeter surpassing FDA guidelines in a UCSF study is a significant development within the health technology sector. The root mean square error (RMSE) average of 2.46% achieved by the Evie Ring not only demonstrates a high level of accuracy but also an improvement over the FDA's requirement of 3.5% for SpO2 measurements. This performance could expedite the FDA's 510(k) clearance process, which is important for the company's transition into the medical device market. The successful clinical performance is a testament to the product's reliability, potentially positioning it favorably against other medical devices.
Moreover, the strategic decision to address FDA comments and present new data from the latest study may strengthen the company's application. The clearance, expected in July 2024, could significantly impact Movano Health's market position, allowing them to tap into both the consumer wellness and medical device segments. The dual functionality of the Evie Ring, serving both consumer and medical needs, could create a unique value proposition in the market.
The integration of comprehensive health metrics in Movano Health's Evie Ring, including SpO2, heart rate variability and menstrual tracking, signifies a broader trend in consumer health devices evolving into medically relevant tools. The wearable's ability to compete with hospital-grade pulse oximeters in terms of accuracy suggests a potential disruption in the traditional medical device industry. As consumers increasingly seek devices that offer both wellness tracking and clinical-grade monitoring, Movano Health's positioning could capture a significant share of this growing market.
From a business perspective, the anticipated FDA clearance for the Evie Med Ring could open up new revenue streams for Movano Health and possibly drive stock market interest. Investors are likely to monitor the company's progress closely, as FDA clearance could lead to increased adoption of the Evie Ring in clinical settings, potentially boosting sales and market share. The emphasis on a user-friendly mobile app that translates complex health data into actionable insights could also enhance consumer engagement and retention, further driving the company's growth.
Movano Health's focus on blending style, personalization and accessibility with medical-grade capabilities in the Evie Ring reflects a growing consumer demand for health technology products that do not compromise on aesthetics. The market for wearable technology is highly competitive and the ability to stand out with a product that caters to both health-conscious consumers and medical patients could be a game-changer. The Evie Ring's design improvements and the simplification of data presentation through its mobile app are strategic moves that could improve user experience and adoption rates.
In the long term, the success of the Evie Ring could set a precedent for consumer wearables to gain medical device status, potentially influencing industry standards and regulatory practices. If Movano Health can successfully navigate the FDA clearance process, it could inspire similar innovations and strategies among competitors, leading to a new wave of health technology products that bridge the gap between consumer and medical applications.
The Evie Ring entered commercial production in late 2023 as a consumer wellness device. This latest UCSF study, completed in the first quarter of 2024, used the production model ring, which reflected several design improvements from the pre-commercial model used in the earlier study and will be submitted to FDA and sold under the brand name Evie Med. During the second trial, each subject wore four Evie Rings. When testing arterial blood gas levels, the four Evie Rings achieved a root mean square error (RMSE) average of
Movano Health believes one of the most critical components of the FDA submission remains the ring's clinical performance. The company plans to address the outstanding FDA comments from August 2023 for the Evie Med Ring in April 2024 and present the corroborating data from the first quarter of 2024 clinical study. Movano Health expects to receive a decision regarding its 510(k) clearance in July 2024.
"Our goal for Evie is to deliver both a consumer and medical device wearable that combines accessibility, personalization and style with the recognized capabilities of a medical device," said John Mastrototaro, CEO of Movano Health. "The results of this latest study lay the groundwork to fulfilling all aspects of that goal. The journey toward establishing ourselves as a medical device company demands considerable effort, yet we view it as a substantial competitive advantage and a valuable asset in comparison to existing wellness solutions. We look forward to continuing to work closely with the FDA throughout this final step in the review process."
The Evie Ring 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 information into actionable insights that will help women make manageable lifestyle changes and take a more proactive approach to mitigating the risks of chronic disease.
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 and their healthcare professionals to utilize daily medical-grade data as a tool to proactively monitor and manage health outcomes. For more information on Movano Health, visit https://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 plans with respect to commercial launch of the Evie Ring; planned cost-cutting initiatives; anticipated FDA clearance for the Evie Ring and other products in development; expected future operating results; product development and features, product releases, clinical trials 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
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