LifeSignals Receives FDA 510(k) Approval for UbiqVue™ 2A Multiparameter System

MILPITAS, Calif., Nov. 25, 2024 /PRNewswire/ -- LifeSignals, Inc. today announced that the UbiqVue 2A Multiparameter System has received FDA Class II 510(k) clearance, marking a significant milestone in continuous wireless patient monitoring for population health management.

UbiqVue 2A Multiparameter System can be deployed in home, remote, and hospital settings – to continuously monitor patients’ physiological data, enhancing patient safety and replacing laborious and potentially inaccurate spot-checks.

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 twelve other monitored parameters, including 2-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. Designed for compatibility with clinical workflows, UbiqVue ensures seamless integration and scalability across healthcare systems.

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