NeuroWave Obtains 510(k) Clearance for NeuroFASTTM Monitoring System (NF-201)

CLEVELAND HEIGHTS, Ohio (December 2010) - NeuroWave Systems Inc. announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the NeuroFAST Monitoring System, Model NF-201, a state-of-the-art EEG acquisition device.

The NeuroFAST NF-201 system is a 2-channel device for brain activity monitoring designed for use in the OR, ICU, ED and other clinical settings. The NeuroFAST system, along with our proprietary disposable EasyPrepTM electrodes, acquires and displays electroencephalographic signals (EEGs) obtained from noninvasive electrodes placed on a patient's forehead. The acquired signals, real-time processed EEG spectral variables and density spectral arrays are continuously displayed by the system for direct interpretation by the clinician. The system monitors both brain hemispheres simultaneously. All data are archived for later review and analysis.

The NeuroFAST has a robust hardware which incorporates electro-surgical interference detection and filtering; cardiac defibrillation protection; continuous measurement of electrode-skin contacts; and advanced automated artifact detection. Furthermore, our electrodes ensure acquisition of high-fidelity EEG signals with minimal skin preparation to facilitate rapid placement and ease of use.

"The NeuroFAST provides medical professionals with a portable, simple-to-use EEG monitor to view and interpret real-time EEG waveforms, processed EEG variables and plots indicative of a patient's brain activity and function. The NeuroFAST benefits from our years of expertise in EEG signal acquisition and processing, and is a robust platform for research in clinical neurophysiology" said Stephane Bibian, NeuroWave's Director of Engineering and Clinical Research. "We take tremendous pride in this regulatory achievement for NeuroWave Systems and as we continue to pioneer advancements in monitoring products using advanced signal processing of brain waves and other biosignals, we look forward to many more similar successes," said Tracie Capozzio, who leads NeuroWave's quality assurance and regulatory compliance.

The development of the NeuroFAST hardware and algorithms was sponsored in part by the US Army, under the grant #W81XWH-06-C-0016, and the NIH, under the grant #6R44NS046978-04.

About NeuroWave:
NeuroWave Systems Inc.'s mission is to develop, manufacture, and market monitoring products using advanced signal processing of brain waves (electroencephalogram - EEG) and other biosignals for Neurology, Anesthesia, Emergency Medicine and Psychiatry applications, in order to improve patient outcome and quality of life.