Cloud-based system, featuring a wearable biosensor with chest SpO2, enables active patient monitoring in all in-hospital and out-of-hospital care environments
Replaces time-consuming manual spot checks with continuous, near real-time active patient monitoring
Web-based system continuously displays physiological data for multiple patients, with visual alarms and alert notifications to streamline patient care
Developed to enable scalable population health management
After FDA 510(k) Clearance
Milpitas, California, United States. December 5, 2024: LifeSignals, Inc. today announced that the UbiqVue 2A multi-parameter system has received EU MDR certification, marking another important milestone in the deployment of wireless continuous patient monitoring for population health management, following 510(k) clearance from the FDA last month. UbiqVue 2A is thus approved and CE marked in accordance with European regulations on medical devices, which guarantees the safety and performance of medical equipment. This is especially important as the UbiqVue 2A multiparametric system is designed to be deployed at home, as well as in hospital settings, to continuously monitor patient physiological data, replacing laborious and potentially inaccurate spot checks
The UbiqVue 2A biosensor is at the heart of the system. It is an all-in-one, single-use wearable device that continuously collects chest SpO2** and other biological data to generate a total of twelve monitored parameters , including two-channel ECG, pulse, PPG, respiratory rate, body temperature and movement. The encrypted data is transmitted securely, in near real time, from the biosensor via a relay application or access point to a secure cloud-based system, where it is then processed. Healthcare professionals and care providers can access vital signs continuously, via the UbiqVue web portal, and receive alert notifications.
“This EU MDR Class IIb certification, typically granted to devices intended for continuous monitoring of vital physiological parameters in anesthesia, intensive care or emergency care, confirms our commitment to providing functionality equivalent to that of a bedside monitor with an affordable, single-use biosensor,” said Surendar Magar, co-founder and CEO of the company. “By obtaining necessary regulatory approvals in various geographies and creating global partnerships with OEMs, service providers and distributors, we aim to transform healthcare at scale.”
The UbiqVue system is expected to play a critical role in improving patient care and population health strategies, furthering LifeSignals’ mission to provide innovative wireless solutions to healthcare systems around the world. To learn more, visit: www.lifesignals.com/ubiqvue-multiparameter/
** Patented white light spectral SpO2 technology licensed from BioIntelliSense, Inc. LifeSignals, Inc. in partnership with BioIntelliSense, performed the product-level design and processing technology enhancements enabling reliable, continuous monitoring of SpO2 and accurate performance for all skin colors in a chest-worn biosensor.
About LifeSignals Inc.
LifeSignals provides scalable patient monitoring solutions for population health. By revolutionizing the way vital biomedical data – the signals of life – is captured and delivered, we are empowering healthcare providers to improve outcomes. Our UbiqVue wireless patient monitoring system features single-use, multi-parameter wearable biosensors, driven entirely by proprietary silicon-on-chip technology. This ready-to-deploy solution provides transparent, accurate and cost-effective patient monitoring in clinical and community settings. Visit www.lifesignals.com to learn more.
About the European Medical Device Regulation (MDR)
The European Medical Devices Regulation (MDR) is an updated version of the European Medical Devices Directive (MDD) which replaced it in 2021. The Medical Devices Regulation is more stringent, more comprehensive and more sensitive to the technology than the Medical Devices Directive, which focuses on the entire product life cycle, including development, testing, manufacturing and long-term use.
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