LifeSignals UbiqVue 2A biosensor gains EU certification
The LifeSignals UbiqVue 2A wireless wearable biosensor has received EU MDR (European Union Medical Device Regulation) certification, enabling it to receive the CE mark and be used in medical settings across the EU.
The wearable has built-in 802.11b Wi-Fi, Bluetooth 5.2 LE, and MBAN wireless connectivity. This allows the device to communicate 12 patient health parameters along with fall, motion, and posture event data continuously to health practitioners from afar through HIPAA- and GDPR-compliant cloud data transfers. The internal memory can store data for up to 12 hours when data communication is not available. A built-in lithium manganese dioxide (LiMnO2) battery powers the single-use wearable up to five days.
The UbiqVue 2A significantly reduces the number of devices required, simplifying the lives of health care providers and patients. Important parameters measured include a patient's blood oxygen saturation, heart rate, respiratory rate, and temperature. The device also has a two-channel electrocardiogram to provide greater insight into the current health of recovering heart patients. Readers with heart conditions can monitor themselves using a smartphone and KardiaMobile Personal EKG Monitor (sold here on Amazon).
A built-in gyroscope and accelerometer provide constant monitoring of patient positions and motion, alerting health providers to problems like an unexpected collapse. The biosensor measures 4.6 x 3.6 x 0.7 in. (116 x 91 x 17 mm), weighs 1.23 oz. (35 g), and is IP24-rated against water splashes.
December 4, 2024
Cloud-Based System, Featuring Wearable Biosensor with Chest-Based SpO2, Enables Active Patient Monitoring Across Hospital and Out-of-hospital Care Settings
Replaces time-consuming manual spot checking with continuous, near real-time active patient monitoring
Web-based system displays multiple patient physiological data continuously, with visual alarms and alert notifications for streamlined patient care
Developed to support scalable population health management
Follows FDA 510(k) Clearance
Milpitas, California, USA. December 5, 2024: LifeSignals, Inc. today announced that the UbiqVue 2A Multiparameter System has received EU MDR Certification, marking another significant milestone in deploying continuous wireless patient monitoring for population health management following FDA 510(k) Clearance last month. UbiqVue 2A is thus approved and CE-marked in accordance with EU regulation on medical devices, which ensures the safety and performance of medical equipment. This is especially significant because the UbiqVue 2A Multiparameter System is designed to be deployed in home, as well as hospital settings to continuously monitor patients’ physiological data, 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 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, via the UbiqVue web portal, and receive alert notifications.
“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 System is expected to play a vital role in advancing both individual patient care and broader population health strategies, reinforcing LifeSignals’ mission to deliver innovative, wireless solutions for healthcare systems worldwide. Learn more by visiting: www.lifesignals.com/ubiqvue-multiparameter/
** 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.
DISCOVER UBIQVUE
About LifeSignals Inc.
LifeSignals delivers scalable patient monitoring solutions for population health. By revolutionizing how vital biomedical data—the signals of life—are captured and delivered, we empower healthcare providers to improve outcomes. Our UbiqVue Wireless Patient Monitoring System features single-use, multiparameter wearable Biosensors fully driven by proprietary system-on-chip silicon technology. This ready-to-deploy solution ensures seamless, accurate, and economical patient monitoring across clinical and community settings. Visit www.lifesignals.com to learn more.
About the European Medical Device Regulation (MDR)
The EU Medical Device Regulation (MDR) is an updated version of the EU Medical Device Directive (MDD) that replaced it in 2021. The MDR is more rigorous, comprehensive and technology aware in comparison with MDD, that focus on the entire product lifecycle, including development, testing, manufacturing, and long-term use.
