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

Cloud-Based System, Featuring Wearable Biosensor with Chest-Based SpO₂, Enables Active Patient Monitoring Across Hospital and Out-of-hospital Care Settings

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.

"This FDA 510(k) approval marks a major milestone in LifeSignals' mission to deliver bedside patient monitor-like functionality through an affordable, single-use disposable Biosensor, enabling population health management," said Surendar Magar, Co-founder and CEO. "It shows our commitment to the vision of expanding the UbiqVue system with additional vital signs and advanced AI capabilities. Through global partnerships with OEMs, service providers, IDTFs, and distributors, we aim to transform healthcare at scale."

"This approval reflects our team's expertise in solving complex engineering challenges and achieving scalable, reliable patient monitoring solutions," said Thomas Varghese, Chief Engineering Officer. "From silicon design and wireless coexistence to collecting multiple vital signs from the chest, the UbiqVue System demonstrates the innovation required to meet the growing demands of modern healthcare."

"The FDA clearance underscores our commitment to delivering scalable solutions," said Saravanan Balasubramanian, VP of Medical Technology & Regulatory Operations. "The UbiqVue System combines the critical parameters of a bedside monitor with a low-cost, single-use Biosensor, enabling streamlined care. We addressed SpO₂ accuracy across diverse skin tones, ensured data security, maintained wireless reliability, and met latency requirements for timely alert generation."

UbiqVue is expected to reshape individual patient care and population health strategies, reinforcing LifeSignals' mission to deliver innovative wireless solutions for healthcare systems globally. Learn more: 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.

** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **

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

BANGKOK, Nov. 25, 2024 /PRNewswire/ -- ZTE Corporation (0763.HK / 000063.SZ), a global leading provider of integrated information and communication technology solutions, in collaboration with TrueBusiness (operating under True Corporation, the leading telecom-tech company in Thailand) and Charoen Pokphand Foods (CPF), has created a collaboration in 5G smart factory using independent private network, known as 5G-in-a-box, at CPF's factory. The successful deployment of 5G in the factory in pilot area* marks a significant milestone in CPF's digital transformation and aligns with Thailand's Industry 4.0 strategy.

Traditional Wi-Fi networks in the food manufacturing industry have struggled to meet the increasing demands of intelligent manufacturing due to limitations in security, latency, coverage, and reliability. To address these challenges, CPF, in collaboration with ZTE and TrueBusiness, has deployed the 5G-in-a-box solution at the factory.  

The project utilizes True's spectrum for dedicated use and employs network slicing technology to ensure Quality of Service and enterprise security. To enhance the cost-effectiveness of 5G deployment, the project has chosen ZTE's iMacro equipment, which is not only cost-effective but also suitable for the food factory environment.

ZTE's cutting-edge iMacro and UniEngine technologies have been leveraged to build the 5G independent private network, addressing the shortcomings of traditional Wi-Fi networks while significantly simplifying the complexity and cost of 5G deployment and network operations.

The collaboration on the 5G-in-a-box deployment at CPF's Center of Engineering Excellence(CEE) marks a significant milestone. CEE uses 5G to enhance communication between machines, human and control system. ZTE demonstrates coverage and penetration capability in the factory area. The result shows significant improvements in data reliability. By utilizing 5G network, CEE can introduce more use cases to improve production efficiency such as Autonomous Guided Vehicles (AGVs), robot, vision inspection, AI, and more.

Through the deployment of the 5G-in-a-box solution, an average latency of 10 ms has been achieved. This cutting-edge deployment enables traffic differentiation and precise control based on various service types, ensuring seamless and efficient data transfer. With a downstream transmission rate of 882 Mbps, the facility boasts rapid transmission speeds, free from the constraints of traditional wiring. The reliability of the equipment has been enhanced to 99.99%, laying a solid foundation for the evolution of deterministic networks and the future of smart manufacturing.  

Media Inquiry: 
ZTE.press.release@zte.com.cn 

** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **

ZTE partners with TrueBusiness and CPF in Thailand to deploy 5G private network, driving smart upgrades in food manufacturing