RT’s Three Key Takeaways:
- FDA Grants 510(ok) Clearance for Chest-Based mostly Monitoring Wearable: The UbiqVue 2A Multiparameter System permits steady monitoring of SpO2, ECG, respiration price, and 10 different important indicators, utilizing a single-use biosensor designed for deployment in house, distant, and hospital settings.
- Cloud-Based mostly Answer Permits Actual-Time Entry to Important Knowledge: Encrypted affected person knowledge is securely transmitted to a cloud-based system, the place it’s processed and made accessible to healthcare suppliers by an online portal with alert notifications.
- Designed for Scientific Integration and Scalability: The wearable system aligns with medical workflows, providing compatibility throughout healthcare programs, improved SpO2 accuracy for various pores and skin tones, and wi-fi performance for well timed alerts.
LifeSignals Inc introduced that the US Meals and Drug Administration (FDA) has granted 510(ok) clearance for its UbiqVue 2A Multiparameter System, a cloud-based affected person monitoring system.
UbiqVue 2A Multiparameter System might be deployed in house, distant, and hospital settings to repeatedly monitor sufferers’ physiological knowledge. Central to the system is the UbiqVue 2A biosensor, a single-use, all-in-one wearable system that allows SpO2 to be repeatedly collected from the chest alongside different biodata for producing a complete of 12 different monitored parameters, together with two-channel ECG, pulse price, PPG, respiration price, physique temperature, and movement.
The encrypted knowledge is securely transmitted, in close to real-time, from the Biosensor through a relay app or an entry level to a safe cloud-based system, the place it’s additional signal-processed. Healthcare professionals and care suppliers can entry steady important indicators from anyplace through the UbiqVue net portal and obtain alert notifications. UbiqVue is designed for compatibility with medical workflows, with integration and scalability throughout healthcare programs.
“The FDA clearance underscores our dedication to delivering scalable options,” says Saravanan Balasubramanian, vp of medical expertise and regulatory operations, in a launch. “The UbiqVue System combines the essential parameters of a bedside monitor with a low-cost, single-use Biosensor, enabling streamlined care. We addressed SpO2 accuracy throughout various pores and skin tones, ensured knowledge safety, maintained wi-fi reliability, and met latency necessities for well timed alert era.”
Picture caption: UbiqVue 2A Multiparameter System
Picture credit score: LifeSignals Inc
