NeuroWave Systems has received CE mark for its NeuroSense Monitoring System, Model NS-701, allowing it to be sold in Europe. The System 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.
NeuroWave Systems said that NeuroSense Monitoring System acquires, records, displays and processes real-time EEG signals on both sides of the forehead with 4 proprietary electrodes.
The brainwaves are analysed using NeuroWave’s WAVCNS (Wavelet Analysis Value for Central Nervous System) index, providing clinicians with the second-by-second brain status and trends for both brain hemispheres. This aids the anesthesiologist, neurologist, doctor, or nurse by providing a simple 0-100 score of the patient’s brain activity. The WAVCNS may be used as an aid in monitoring the effects of certain anesthetic agents on adult patients.
Tatjana Zikov, president of NeuroWave Systems, said: “This is a big day for the NeuroWave Systems’ team as we have been working toward this goal for eight years. We are committed to developing innovative brain monitoring technologies for improved cerebral protection and patient outcomes.”
Stephane Bibian, director of Engineering and Clinical Research at NeuroWave Systems, said: “The NeuroSense Monitor is a potential paradigm-shifting technology due to its ability to provide continuous and delay-free tracking of changes in the patient’s brain status.
“The NeuroSense is the brain function monitor that calculates independent indices of brain activity for each brain hemisphere, which is important for detecting brain asymmetry due to pathology (such as stroke) or unrecognised artifacts. The System has been in use for clinical research in Europe for the past three years. We welcome this opportunity to market and sell our system in markets where CE Mark is recognised.”