On Feb. 20, 2024, X-trodes announced the FDA has granted 510(k) clearance for its Smart Skin solution, a new wireless wearable technology for advanced electrophysiological monitoring.
About X-trodes Smart Skin
X-trodes’ Smart Skin is comprised of dry-printed multi-modal electrode patches that conform to the body without requiring gels or wires. Smart Skin monitors a range of signals to acquire brain activity, cardiac monitoring, eye movement and muscle activity data. The flexible, ultra-thin patches attach anywhere on the skin.
This wearable, wireless solution allows access to real-time electrophysiological data and enables freedom of movement for patients in health care and home settings.
According to the company, this FDA clearance follows the successful completion of an assessment to evaluate the accuracy of X-trodes’ system. Results suggest that the technology is 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 measuring electrophysiological signals outside of laboratory settings. With FDA clearance, X-trodes will pursue further validations for a wide range of clinical use cases.
X-trodes’ Smart Skin solution will be marketed as X-trodes System M.
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