Movano Inc., 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 2% margin of error, well below the FDA’s 4% requirement for SpO2. In addition, the Ring also estimated heart rate with accuracy commensurate with the FDA’s standards.
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, visit www.movano.com.