LifeSignals Gains FDA 510(k) Clearance for UbiqVue™ 2A Multiparameter System
LifeSignals has announced FDA Class II 510(k) clearance for its UbiqVue 2A Multiparameter System, a breakthrough in continuous wireless patient monitoring. The system integrates wearable biosensor technology with a secure, cloud-based platform, enabling seamless monitoring of multiple vital signs in hospitals, remote care, and home settings.
At the heart of the system is the UbiqVue 2A Biosensor, a single-use, chest-worn device that continuously tracks SpO2 and other critical parameters, including ECG, pulse rate, respiration, body temperature, and motion. Data is securely transmitted in near real-time via a relay app or access point to the cloud, where it is processed and accessible through the UbiqVue web portal. Healthcare professionals benefit from 24/7 visibility of patient vitals, customizable alerts, and streamlined integration into existing clinical workflows, supporting scalable population health management.
“This clearance is a significant step in our mission to deliver bedside monitor functionality in an affordable, disposable biosensor,” said Surendar Magar, Co-founder and CEO of LifeSignals. “With UbiqVue, we aim to revolutionize healthcare at scale by enabling continuous monitoring and enhancing patient safety through global partnerships with OEMs, providers, and distributors.” The UbiqVue System also prioritizes inclusivity and reliability. “Our team addressed SpO2 accuracy across diverse skin tones, ensured robust wireless performance, and optimized alert latency to meet modern healthcare demands,” added Saravanan Balasubramanian, VP of Medical Technology & Regulatory Operations. LifeSignals plans to expand the UbiqVue platform with additional features, including advanced AI capabilities, further advancing patient care across the continuum.
