Does the VySys wearable wireless biosensor accurately measure vital signs compared to a commercial medical-grade device in clinical subjects?
The VySys wearable wireless biosensor system demonstrates high accuracy and precision for continuous vital signs monitoring compared to commercial medical-grade devices.
A compact, light-weight and low-power wireless vital signs monitoring system based on Wireless Body Area Network (WBAN) protocol has been developed. The system, VySys, includes two compact wearable wireless biosensor devices for continuous vital signs capturing and transmission, a gateway to relay the message collected from the biosensors to cloud, and finally a client apps to access and display the stored data in the cloud. Both biosensor devices can last for 24 hours and weigh less than 22 g and 44 g, respectively.They consist of proprietary in-house bio-sensing integrated circuit (IC) and commercial off-the-shelf Bluetooth Low Energy (BLE) module. VySys has been deployed in clinical trials with 14 subjects. From the studies, the accuracy and advantage of VySys are evaluated and the five vital signs captured (heart rate (HR), respiration rate (RR), temperature (TMP), oxygen saturation (SpO2) and systolic blood pressure (SBP)) are benchmarked against a commercial medicalgrade device. The results show strong statistical correlation (r > 0.68). In terms of clinical significance, all its mean difference are within limits of accepted clinical discrepancies. In terms of efficacy by comparing against the best known reported results, (1) VsSys is more precise by 28.2%, 36.2%, 70.0%, 37.6% and 34.4% for HR, RR, TMP, SpO 2 and SBP, respectively and (2) has a narrower 95% limit of agreement (LoA) by 24.5%, 23.9%, 50.6%, 37.4% and 34.4% for HR, RR, TMP, SpO 2 and SBP, respectively.
Wong et al. (Wed,) studied this question.