#USA #FDA Approval #LifeSignals #UbiqVue 2A #Milpitas

LifeSignals Achieves FDA Approval for UbiqVue™ 2A Multiparameter Monitoring System

LifeSignals, Inc., based in Milpitas, California, is proud to announce that it has received FDA Class II 510(k) clearance for its innovative UbiqVue™ 2A Multiparameter System. This landmark approval signifies a transformative leap in patient monitoring technology, enabling continuous, wire-free capturing of vital signs from patients located in hospitals, remote clinics, or their own homes.

The UbiqVue 2A system is designed for active patient monitoring, reducing the reliance on time-consuming manual spot-checks with a cloud-based wearable biosensor. This system continuously displays multiple physiological data parameters, offering visual alerts and notifications that streamline patient care management. Developed for scalable solutions in population health management, the device emphasizes patient safety and efficiency.

Key Features and Functionality

At the heart of the UbiqVue 2A is a compact, all-in-one wearable biosensor that effectively collects peripheral capillary oxygen saturation (SpO2) from the chest. This versatile device is capable of monitoring a total of 12 vital signs, including two-channel ECG, pulse rate, photoplethysmography (PPG), respiration rate, body temperature, and motion tracking in real-time. The encrypted data collected is then securely transmitted via a relay application to a cloud-based network, ensuring healthcare providers can access vital signs and receive alerts from anywhere.

Healthcare professionals benefit from the UbiqVue 2A’s seamless integration into existing clinical workflows, promoting a hassle-free approach to patient monitoring that enhances accessibility. As described by Surendar Magar, Co-founder and CEO, this FDA clearance is a vital milestone in delivering functionality reminiscent of traditional bedside monitors, all through a cost-effective, single-use biosensor.

Impact on Patient Care

The implications of the UbiqVue 2A stretch beyond mere data collection; it represents a monumental step towards achieving effective population health management strategies. In the words of key product leaders, the system exemplifies a rigorous approach to addressing challenges within modern healthcare, including varied skin tones for SpO2 accuracy, stringent data security protocols, and a commitment to wireless reliability. The approval also reinforces the company’s vision of scaling up the UbiqVue with additional vital signs and advanced AI capabilities, ensuring that healthcare providers remain at the forefront of patient management.

“We believe the UbiqVue System will reshape individual patient care, allowing healthcare providers to monitor a wide array of physiological parameters in real-time, which is critical during emergencies,” stated Thomas Varghese, Chief Engineering Officer. “Our team tackled several engineering challenges to create a product that fulfills the growing demands of healthcare in a continuous, reliable manner.”

Future of UbiqVue Technology

LifeSignals remains committed to influencing the global healthcare landscape through innovative solutions. The UbiqVue system, strengthened by partnerships with OEMs, service providers, IDTFs, and distributors, has the potential to not only enhance individual patient experiences but also revolutionize community health management practices. As highlighted by Saravanan Balasubramanian, VP for Medical Technology Regulatory Operations, this approval is only the beginning; the UbiqVue System allows for a level of monitoring that integrates critical bedside monitor attributes while ensuring that it remains affordable and easy to use.

In conclusion, the FDA's clearance of the UbiqVue 2A Multiparameter System marks a significant milestone for LifeSignals and paves the way for a new era in healthcare monitoring technology. With a focus on patient safety, scalability, and accessibility, UbiqVue is set to change the landscape of health management, ensuring that high-quality patient care is achievable and widespread, making it an essential tool in modern healthcare delivery. For more information about LifeSignals and the UbiqVue system, visit www.lifesignals.com.