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Wearable 'Skin' Solution by X-trodes Granted FDA 510(k) Clearance, Enabling Medical-Grade Electrophysiological Monitoring in Home Settings

Wednesday, February 21, 2024

X-trodes, a pioneering bio-convergence company focused on bringing wireless monitoring solutions to homes, has announced the FDA's clearance of its Smart Skin solution (marketed as X-trodes System M). This marks a significant milestone in advanced electrophysiological monitoring.

The Smart Skin system consists of customizable dry-printed multi-modal electrode patches capable of monitoring various biopotential signals from anywhere on the body. It offers EEG (brain activity), EKG/ECG (cardiac monitoring), EOG (eye movement), and EMG (muscle activity) data without the need for gels, wires, or discomfort. These discreet patches are easy to apply and comfortable, conforming to the body's contours.

The FDA clearance follows rigorous scientific assessments confirming the accuracy and reliability of X-trodes' system. It demonstrated performance equivalent to FDA-cleared clinical electrophysiology devices for measuring EEG, EOG, EMG, and EKG/ECG signals. This clearance validates the value of X-trodes' technology in enhancing health and wellness through real-time electrophysiological data access, facilitating various clinical applications.

Traditionally, electrophysiological monitoring has been limited to clinics, requiring bulky hardware and controlled environments. X-trodes' Smart Skin transforms monitoring by encapsulating a comprehensive monitoring lab into a discreet, flexible, and entirely wireless skin patch. It enables continuous medical-grade monitoring in any environment, offering users unprecedented convenience and access to critical physiological data.