LifeSignals has received EU MDR Certification for its UbiqVue 2A Multiparameter System. UbiqVue 2A is thus approved and CE-marked under EU regulations on medical devices, which ensures the safety and performance of medical equipment. This follows the system’s FDA 510(k) Clearance last month.

The UbiqVue 2A Multiparameter System is designed to be deployed in the home, as well as hospital settings, for continuous monitoring of patients’ physiological data, replacing laborious and potentially inaccurate spot-checks.

“This Class IIb EU MDR Certification, typically given to devices intended for the continuous surveillance of vital physiological parameters in anesthesia, intensive care or emergency care, confirms our commitment to deliver bedside patient monitor-equivalent functionality through an affordable, single-use Biosensor,” said Surendar Magar, Co-founder and CEO. “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 2A Biosensor is a single-use, all-in-one wearable device that enables SpO₂* to be continuously collected from the chest alongside other biodata, generating 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. 

* 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 SpO₂monitoring and accurate performance across all skin tones in a chest-worn Biosensor.