Summary: LifeSignals’ UbiqVue 2A Multiparameter System has received FDA Class II 510(k) clearance. The single-use Biosensor enables continuous monitoring of SpO2 and 12 other parameters, securely transmitting data in real-time for remote or in-hospital use.

Key Takeaways:

  • FDA Clearance for Innovation: The UbiqVue 2A System combines affordability and advanced monitoring, enhancing patient care across home, remote, and hospital settings.
  • Scalable and Secure: With encrypted real-time data transmission and compatibility with clinical workflows, the system ensures seamless integration for healthcare providers.

LifeSignals, Inc., announced that the UbiqVue 2A Multiparameter System wireless patient monitoring system has received FDA Class II 510(k) clearance.

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.

RELATED: FDA Updates Guidance on Third-Party 510(k) Review Program

Innovative UbiqVue 2A Biosensor Technology

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
  • 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.

Real-Time Data Access for Healthcare Providers

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 enables 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.”