NeuroWave Receives Medical Device License from Health Canada for its NeuroSENSE Monitoring System
CLEVELAND HEIGHTS, Ohio (August 12, 2011) - NeuroWave Systems Inc. announced today that Health Canada has granted a Class III Medical Device License for its NeuroSENSE® Monitoring System, Model NS-701, allowing it to be commercialized in Canada. This system is already CE-marked for sale in the European Union.
The NeuroSENSE Monitoring System, Model NS-701, is a bilateral non-invasive electroencephalographic (EEG) device to monitor the brain function in the operating room, intensive care unit, emergency room and other clinical settings. This system acquires and processes EEG signals from each brain hemisphere, obtained using 4 proprietary electrodes placed on patient’s forehead. The acquired raw EEG signals and processed EEG variables are continuously displayed and recorded by the system for interpretation by the clinician. The proprietary processed variable, WAVCNS (Wavelet Analysis Value for Central Nervous System), quantifies the patient’s brain activity, providing a simple 0-100 score for both hemispheres independently. This second-by-second WAVCNS index may be used as an aid in monitoring the effects of certain anesthetic agents on adult patients.
"Most of the NeuroSENSE original device concept and core algorithms originated from the efforts of a multi-disciplinary team including anesthesiologists and researchers from the University of British Columbia. We are very proud to bring this technology back to Canada and offer its benefits to Canadian people," said Tatjana Zikov, NeuroWave Systems' President.
The NeuroSENSE Monitor will be distributed in Canada by Caster Medical Systems (Oakville, Ontario; www.castermedical.com) and Braemed Ltd. (Dartmouth, Nova Scotia; www.braemed.ca).
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, Intensive Care Unit, Emergency Medicine and Psychiatry
applications, in order to improve patient outcome and quality of life.
For further information regarding NeuroWave Systems Inc., visit the Company's website at www.neurowavesystems.com.