NeuroWave Systems Approved by the FDA for Brain Monitoring During Anesthesia

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 NeuroWave Systems Inc. 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.

The market for brain wave-monitoring devices used during anesthesia is estimated at more than $1 billion a year and growing, according to CleveMed. The market is dominated by Aspect Medical Systems Inc. in Norwood, Massachusetts, according to Neurotech Business Report. Aspect was acquired last year by medical products supplier Covidien (NYSE:COV).