FDA clears wearable EP monitoring patch from X-trodes

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…

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