Patient monitoring solutions provider LifeSignals has received European Union (EU) Medical Device Regulation (MDR) certification for its UbiqVue 2A Multiparameter System.
This certification follows the US Food and Drug Administration (FDA) 510(k) clearance granted to the system last month.
UbiqVue 2A is now CE-marked and complies with EU medical device regulations.
The system is designed for continuous wireless patient monitoring and population health management. It is intended for use in both home and hospital settings.
It continuously tracks patient physiological data, replacing traditional spot-checks with more accurate and proactive monitoring.
The UbiqVue 2A biosensor is a single-use, all-in-one wearable device that continuously monitors oxygen saturation (SpO2) and other vital parameters from the chest, generating a total of 12 monitored parameters. These include a two-channel electrocardiogram (ECG), pulse rate, photoplethysmography (PPG), respiration rate, body temperature, and motion.
Encrypted data from the biosensor is transmitted securely in near real-time from the Biosensor to a cloud-based system via a relay app or access point for further signal processing.
Healthcare professionals and care providers can access continuous vital signs through the UbiqVue web portal. They also receive visual alarms and alert notifications for any changes in patient health, thereby streamlining patient care.
LifeSignals co-founder and CEO Surendar Magar said: “This Class IIb EU MDR Certification, typically given to devices intended for the continuous surveillance of vital physiological parameters in anaesthesia, intensive care or emergency care, confirms our commitment to deliver bedside patient monitor-equivalent functionality through an affordable, single-use Biosensor.
“By securing the 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 aims to advance patient care and population health strategies. It aligns with LifeSignals’ mission to provide new, wireless healthcare solutions globally.
LifeSignals also offers LifeSignals LX1550 Multiparameter Remote Monitoring Platform which was cleared by the FDA in 2021.
