The cloud-based monitoring solution uses a single-use biosensor to track vital signs like SpO2, ECG, and body temperature across home, remote, and hospital settings.
RT’s Three Key Takeaways:
- FDA Grants 510(k) Clearance for Chest-Based Monitoring Wearable: The UbiqVue 2A Multiparameter System allows continuous monitoring of SpO2, ECG, respiration rate, and 10 other vital signs, using a single-use biosensor designed for deployment in home, remote, and hospital settings.
- Cloud-Based Solution Enables Real-Time Access to Vital Data: Encrypted patient data is securely transmitted to a cloud-based system, where it is processed and made accessible to healthcare providers through a web portal with alert notifications.
- Designed for Clinical Integration and Scalability: The wearable device aligns with clinical workflows, offering compatibility across healthcare systems, improved SpO2 accuracy for diverse skin tones, and wireless functionality for timely alerts.
LifeSignals Inc announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for its UbiqVue 2A Multiparameter System, a cloud-based patient monitoring system.
UbiqVue 2A Multiparameter System can be deployed in home, remote, and hospital settings to continuously monitor patients’ physiological data. Central to the system is the UbiqVue 2A biosensor, a single-use, all-in-one wearable device that enables SpO2 to be continuously collected from the chest alongside other biodata for generating a total of 12 other monitored parameters, including two-channel ECG, pulse rate, PPG, respiration rate, body temperature, and motion.
The encrypted data is securely transmitted, in near real-time, from the Biosensor via a relay app or an access point to a secure cloud-based system, where it is further signal-processed. Healthcare professionals and care providers can access continuous vital signs from anywhere via the UbiqVue web portal and receive alert notifications. UbiqVue is designed for compatibility with clinical workflows, with integration and scalability across healthcare systems.
“The FDA clearance underscores our commitment to delivering scalable solutions,” says Saravanan Balasubramanian, vice president of medical technology and regulatory operations, in a release. “The UbiqVue System combines the critical parameters of a bedside monitor with a low-cost, single-use Biosensor, enabling streamlined care. We addressed SpO2 accuracy across diverse skin tones, ensured data security, maintained wireless reliability, and met latency requirements for timely alert generation.”
Photo caption: UbiqVue 2A Multiparameter System
Photo credit: LifeSignals Inc
