FDA Clears X-trodes' Wireless Wearable 'Skin' for Electrophysiological Monitoring

The Smart Skin is comprised of customizable dry-printed multi-modal electrode patches.

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X-trodes today announced that the FDA has granted 510(k) clearance for X-trodes' Smart Skin solution (marketed as X-trodes System M), a new wireless wearable technology for advanced electrophysiological monitoring. 

X-trodes’ Smart Skin is comprised of customizable dry-printed multi-modal electrode patches. It monitors a wide range of biopotential signals from anywhere on the body to acquire EEG (brain activity), EKG/ECG (cardiac monitoring), EOG (eye movement), and EMG (muscle activity) data. The discreet patches are easy to apply and comfortable to wear, conforming to the body without requiring gels, wires or uncomfortable solutions.

The FDA clearance follows successful completion of an extensive scientific assessment that evaluated the accuracy and consistency of X-trodes’ system. The study showed the performance of the X-trodes technology to be equivalent to that of FDA-cleared clinical electrophysiology devices in measuring EEG, EOG, EMG, and EKG/ECG signals.

Smart Skin is already available to researchers seeking unprecedented accuracy when measuring electrophysiological signals outside of laboratory settings. Having achieved FDA 510(k) clearance, X-trodes will pursue further validations for a wide range of clinical use cases, with an initial focus on the cardiovascular and sleep monitoring markets.

Electrophysiological monitoring has traditionally been restricted to clinics, requiring cumbersome hardware and controlled environments to acquire highly sensitive physiological signals. X-trodes' Smart Skin encapsulates an entire monitoring lab into a discreet, flexible and completely wireless skin patch that provides continuous medical-grade monitoring in any environment that users may find themselves.

X-trodes' technology is backed by more than 15 years of research at Prof. Yael Hanein’s neuro engineering lab at Tel Aviv University and scientifically validated patents. Its efficacy has been supported by several peer-reviewed studies published in leading journals, including Nature Scientific Reports and the Journal of Neural Engineering.

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