Movano Ring Exceeds Accuracy Targets for SpO2 and Heart Rate Monitoring in Initial Hypoxia Study; Company Eyes FDA Submission
Movano Inc. (NASDAQ: MOVE) announced a successful study with UCSF, demonstrating the accuracy of the Movano Ring in measuring blood oxygen saturation (SpO2) and heart rate. The device achieved a 2% margin of error for SpO2, surpassing FDA's 4% requirement. Conducted with seven subjects, the study validated the ring's performance during varying levels of hypoxia. Movano plans to conduct a larger pivotal study for FDA submission later this year, moving closer to providing trusted health data for consumers and healthcare professionals.
- Achieved a 2% margin of error for SpO2, well below FDA's requirement.
- Plans for a larger pivotal study indicating commitment to FDA submission.
- Successful validation of heart rate monitoring accuracy.
- None.
Vital health metric demonstrates wearable's potential to properly track heart health and detect possible illnesses
PLEASANTON, Calif., Aug. 9, 2022 /PRNewswire/ -- Movano Inc. (NASDAQ: MOVE), a purpose-driven healthcare solutions company at the intersection of medtech and consumer devices, announces today the successful completion of a study with the University of California San Francisco (UCSF) to assess the accuracy of the Movano Ring's blood oxygen saturation (SpO2) and heart rate data. With results that exceeded the requirements of the industry standard used by FDA for evaluating SpO2 devices, this successful study is a promising step toward the company's goal to provide medically-validated data to consumers and healthcare professionals.
The study was conducted on seven subjects of mixed genders and ethnicities and followed the same protocol that we expect will be required by the FDA for the submission. Wearing a Movano Ring prototype and reference devices within a controlled environment, each participant's oxygen levels were driven down to as low as 70 percent and then back up to 100 percent to test the accuracy of Movano's device during mild, moderate and severe hypoxia. The prototype also measured heart rate during this time and participants' heart rate varied from 60 to 120 beats per minute as they were being deprived of oxygen.
In comparing the overall accuracy of the Ring's data with that of the reference devices, the Movano Ring resulted in a
As Movano eyes its first FDA submission, validating the device's ability to measure blood oxygen levels, heart rate and other vitals is a top priority for the company. Based on the positive results from this study, Movano plans to conduct a larger pivotal study for the FDA submission later this year.
"The FDA has a high threshold for accuracy and requires an extensive investment by any company to prepare to meet these standards. This hypoxia study is a promising display of the quality metrics our ring can deliver," said John Mastrototaro, CEO of Movano. "While this outcome is an exciting step toward the FDA submission, what it really means for consumers and healthcare providers is we're one step closer to being able to trust and utilize the ring data in a meaningful way."
For more information on Movano and the Movano Ring, visit www.movano.com.
About Movano
Founded in 2018, Movano Inc. (NASDAQ:MOVE) 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's wearables 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's end-to-end solutions will soon enable a world where consumers, caretakers and healthcare professionals can utilize daily health data as a tool to proactively monitor and manage their health. For more information, visit www.movano.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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