FDA Clears Wearable Electrophysiological Monitoring Patch to Record EEG, EOG, EMG, and EKG Data

The Food and Drug Administration (FDA) has granted 510(k) clearance to Smart Skin (X-trodes System M; X-trodes, Tel Aviv, Israel). Smart Skin is a wireless wearable system for medical-grade electrophysiological monitoring for at-home use, available as a dry-printed multi-modal electrode patch. The system is designed to be discrete, easy, and comfortable to wear, while providing neurologists with accurate, continuous, real-time measurements of electrophysiological data outside of traditional clinical settings. While Smart Skin is already available for use by researchers, X-trodes states that the new clearance will expand the system towards clinical applications for people with cardiovascular and sleep disorders.

According to a statement from X-trodes, Smart Skin’s 510(k) clearance is based on results of a study that determined that the system is accurate and consistent in its monitoring of electrophysiological data. The results suggest that Smart Skin was equivalent to other devices with FDA clearance that measure electroencephalogram (EEG), electrooculogram (EOG), electromyography (EMG), and electrocardiogram (EKG) data.

“The X-trodes system is the next generation of wearable and fully wireless solutions, enabling clinicians and researchers to unleash the full potential of medical-grade electrophysiological monitoring,” said Ziv Peremen, PhD, CEO of X-trodes. “Gaining FDA clearance affirms the value of this technology and its potential to improve health and wellness through access to real-time electrophysiological data. It will further shorten the path to commercialization for a range of clinical use cases.”