US FDA approval for wearable electrophysiology monitoring system

Posted under: Smart Technologies
Date: 2024-02-21
US FDA approval for wearable electrophysiology monitoring system

X-trodes has received FDA 510(k) clearance for its Smart Skin solution, the X-trodes System M, a wireless wearable technology for advanced electrophysiological monitoring. This system utilizes customizable dry-printed multimodal electrode patches to monitor EEG, EKG/ECG, EOG, and EMG signals from various parts of the body. Extensive scientific assessment demonstrated its accuracy and consistency equivalent to FDA-cleared clinical devices. CEO Ziv Peremen highlights its potential to enhance healthcare by providing real-time electrophysiological data. With FDA clearance, X-trodes aims to validate its system for cardiovascular and sleep monitoring, addressing gaps in remote monitoring for neurology and cardiology departments. VP Deganit Barak Shinar emphasizes its potential to improve patient experience and outcomes across clinical settings, including home care.

Read more at: cardiacrhythmnews.com