Sam Brusco, Associate Editor02.20.24
X-trodes has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Smart Skin solution (X-trodes System M), a wireless wearable technology for advanced physiological monitoring.
Smart Skin is composed of customizable, dry-printed, multi-modal electrode patches. It monitors a variety 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.
Typically, electrophysiological monitoring has been restricted to clinics and needs cumbersome hardware and controlled environments to acquire sensitive physiological signals. X-trodes’ Smart Skin combines an entire lab into a discreet, flexible, wireless skin patch that offers continuous, medical-grade monitoring in any environment.
The company said the patches are simple to apply and comfortable, conforming to the body without needing gels or wires.
This clearance follows completion of a scientific assessment that evaluated the X-trode system’s accuracy and consistency. The study demonstrated that X-trodes technology is equivalent to FDA-cleared, clinical electrophysiology devices that measure EEG, EOG, EMG, and EKG/ECG signals.
The company said it will pursue more validations for a wide range of clinical uses, with its first focus on cardiovascular and sleep monitoring.
"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, Ph.D., 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."
Smart Skin is composed of customizable, dry-printed, multi-modal electrode patches. It monitors a variety 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.
Typically, electrophysiological monitoring has been restricted to clinics and needs cumbersome hardware and controlled environments to acquire sensitive physiological signals. X-trodes’ Smart Skin combines an entire lab into a discreet, flexible, wireless skin patch that offers continuous, medical-grade monitoring in any environment.
The company said the patches are simple to apply and comfortable, conforming to the body without needing gels or wires.
This clearance follows completion of a scientific assessment that evaluated the X-trode system’s accuracy and consistency. The study demonstrated that X-trodes technology is equivalent to FDA-cleared, clinical electrophysiology devices that measure EEG, EOG, EMG, and EKG/ECG signals.
The company said it will pursue more validations for a wide range of clinical uses, with its first focus on cardiovascular and sleep monitoring.
"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, Ph.D., 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."