Once, wearable devices were mainly used for step tracking. However, in recent years, they've evolved to become more sophisticated, efficient, and compact. Not only do these devices promote greater health awareness, but they're also becoming integral to healthcare. To expedite their integration into healthcare settings, both consumers and healthcare professionals must trust the accuracy of wearable health data.
We're currently planning to seek FDA medical device clearance for the Qring pulse oximeter, encompassing heart rate and blood oxygen saturation (SpO2) data.
QRing is poised to deliver dependable, medical-grade data for your use in discussions with healthcare teams, coaches, and family members, facilitating the connection between your well-being and your subjective experiences. For more information, refer to our press release.
The clinical performance of Qring surpasses FDA standards. We recently concluded a successful clinical trial in collaboration with a prestigious university, assessing the accuracy of Evie SpO2. When compared to arterial blood gas data, Evie's ring demonstrated an error rate of approximately 1.9%, well below the FDA's 3.5% guideline for SpO2 accuracy. Additionally, in another non-clinical test evaluating pulse accuracy, conducted in accordance with standards and FDA guidance, the Qring exhibited an error rate of no more than 1 per minute, further exceeding FDA requirements.
