LifeSignals has been granted FDA 510(k) approval for the UbiqVue™ 2A Multiparameter System.
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UbiqVue™ 2A Multiparameter System is based around a wearable ciosensor with chest-based SpO_2
LifeSignals, Inc. Announces FDA Clearance for UbiqVue 2A Multiparameter System
WNPH | MILPITAS, Calif., Nov. 25, 2024 – LifeSignals, Inc. is proud to announce that the UbiqVue 2A Multiparameter System has received FDA Class II 510(k) clearance. This marks a significant achievement in the realm of continuous wireless patient monitoring for population health management. The UbiqVue 2A Multiparameter System is designed to provide continuous monitoring of patients’ physiological data in home, remote, and hospital settings, replacing manual spot-checks with near real-time monitoring to enhance patient safety.
Key features of the UbiqVue 2A Multiparameter System include a wearable biosensor with chest-based SpO2 monitoring. The system displays multiple patient physiological data continuously, with visual alarms and alert notifications for streamlined patient care. The UbiqVue 2A Biosensor collects twelve monitored parameters, including ECG, pulse rate, respiration rate, body temperature, and motion, securely transmitting the data to a cloud-based system for further processing.
“This FDA clearance is a significant milestone for LifeSignals in our mission to provide affordable, scalable patient monitoring solutions for population health management,” said Surendar Magar, Co-founder and CEO. “We are committed to expanding the capabilities of the UbiqVue system with advanced AI features to transform healthcare on a global scale.”
The UbiqVue System has been developed to meet the demands of modern healthcare, with a focus on accuracy, reliability, and data security. By combining vital sign monitoring with a low-cost, single-use Biosensor, UbiqVue aims to streamline patient care and improve population health strategies.
For more information about UbiqVue and LifeSignals’ innovative wireless solutions, visit www.lifesignals.com.
** White light spectral SpO2 patented technology licensed from BioIntelliSense, Inc. LifeSignals, Inc. in partnership with BioIntelliSense, carried out the product-level design and processing technology enhancements enabling reliable, continuous SpO2 monitoring and accurate performance across all skin tones in a chest-worn Biosensor.
