NeuroWave Systems Approved by the FDA for Brain Monitoring During Anesthesia
Posted Dec 10 2010 2:08am
The device is to be used during anesthesia, which would be during surgical procedures and this is the first device approved for NeuroWave. The company has used grants and other donations to get started and had not had any investors, so a lot of work and hopefully the product will make it’s way to hospitals to be used when brain monitoring would be needed. BD
Medical device startup has received regulatory clearance from the Food and Drug Administration to begin selling a brain-activity monitoring system.
The Cleveland Heights, Ohio-based company’s NeuroFAST Monitoring System is intended for use in hospital operating rooms, emergency departments and intensive care units, plus for clinical research. The system monitors both brain hemispheres and acquires and displays electroencephalographic signals (EEGs) — which are produced by neurons firing in the brain — obtained from electrodes placed on a patient’s forehead, according to a statement from the company.