NeuroWave Systems has received 510(k) clearance from the US Food and Drug Administration (FDA) for the NeuroFAST Monitoring System, an EEG acquisition device.

The NeuroFAST NF-201 system is a 2-channel device for brain activity monitoring, which can be used in the OR, ICU, ED and other clinical settings.

The NeuroFAST system acquires and displays electroencephalographic signals (EEGs) obtained from the non-invasive electrodes place on the patient’s forehead.

The system displays acquired signals, real-time processed EEG spectral variables and density spectral arrays for direct interpretation by the clinician, and the data can also be archived for later review and analysis.

The system can also monitor both brain hemispheres simultaneously.