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LifeSignals Achieves EU MDR Certification for UbiqVue 2A Multiparameter System

LifeSignals, Inc. has announced a remarkable advancement in healthcare technology with the recent receipt of EU MDR (Medical Device Regulations) Certification for its UbiqVue 2A Multiparameter System. This certification, which is pivotal for launching medical devices in Europe, underscores the system's safety and performance, solidifying its place in the growing field of wireless patient monitoring.

The UbiqVue 2A system integrates a state-of-the-art wearable biosensor capable of continuously monitoring critical physiological data. Unlike traditional methods that rely on manual spot-checks, UbiqVue offers near real-time monitoring, enhancing patient care significantly. This innovation is expected to revolutionize monitoring in both hospital environments and at home, allowing healthcare providers to respond more promptly to patient needs.

Central to the UbiqVue 2A application is its single-use biosensor, which attaches comfortably to a patient's chest. This device not only monitors SpO2 levels but also gathers comprehensive data on various parameters such as ECG readings, pulse rates, respiration rates, and body temperature—all within a single sensor. The information is transmitted securely to a cloud-based system, where healthcare professionals can track the metrics through a web portal that provides visual alarms and alerts.

Surendar Magar, Co-founder and CEO of LifeSignals, articulated the importance of this certification by stating, "This Class IIb EU MDR Certification is especially significant as it reflects our commitment to provide hospital-grade continuous monitoring through an economical solution. We believe our biosensor can significantly improve patient care in different healthcare settings."

Additionally, the UbiqVue 2A Multiparameter System had previously received FDA 510(k) clearance, indicating that it has met the regulatory standards set by the United States Food and Drug Administration. It highlights the product's dual regulatory clearance allowing for broader adoption across multiple healthcare jurisdictions.

As healthcare systems globally strive for better outcomes through advanced technologies, LifeSignals’ approach aims to ensure seamless integration of patient monitoring systems. By keeping healthcare professionals connected with vital signs data in real-time, the UbiqVue system enhances clinical decision-making processes.

LifeSignals supports the growing need for scalable population health management solutions. The UbiqVue Wireless Patient Monitoring System is designed with proprietary system-on-chip technology that guarantees quick deployment across various clinical and community settings while maintaining cost-efficiency.

Importantly, the technology originates from a partnership with BioIntelliSense, which has contributed patented SpO2 technology to the UbiqVue system. This collaboration has led to significant enhancements in the reliability and accuracy of monitoring across varied skin tones, addressing a critical need in health equity.

In summary, LifeSignals’ UbiqVue 2A Multiparameter System represents more than just technological advancement; it symbolizes a fundamental shift towards better, more proactive patient care. With ongoing developments in wireless health monitoring, platforms like UbiqVue are set to play a central role in the future of medical care. For more information about the UbiqVue system, visit LifeSignals' official website.