X-trodes announced today that it received FDA 510(k) clearance for a new wireless wearable technology for electrophysiological (EP) monitoring.
The Herzliya, Israel-based company calls its solution “Smart Skin,” although it plans to market it in the U.S. as the X-trodes System M.
Smart Skin features a customizable, dry-printed, multi-modal electrode patches. It monitors a wide range of biopotential signals from anywhere on the body. The system acquires EEG, EKG/ECG, EOG and EMG data. The discreet patches offer easy application and comfort. X-trodes designed them to conform to the body without requiring gels, wires or uncomfortable solutions.
The system encapsulates an entire monitoring lab into a discreet, flexible and completely wireless skin patch. X-trodes said Smart Skin can provide continuous, medical-grade monitoring in any environment users may find themselves in.
According to a news release, FDA clearance follows assessments of the system’s accuracy and consistency. The company’s study found equivalent performance compared to FDA-cleared clinical electrophysiology devices measuring EEG, EOG, EMG and EKG/ECG signals.
X-trodes already offered Smart Skin to researchers but can now pursue further validations for a range of clinical uses. It plans to first target the cardiovascular and sleep monitoring markets.
“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, 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.”
