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.
“It’s the first FDA-cleared device that NeuroWave has, so that’s a real big deal,” said Bob Schmidt, NeuroWave’s chairman. “This is a big step for us as a growing company.”
In June, the company received European regulatory clearance to begin selling its NeuroSENSE brain monitor for assessing the level of anesthesia. That device has similar hardware to the NeuroFAST system but operates on more-sophisticated algorithms for automated EEG interpretation, according to Schmidt.
Because the company has been focusing its efforts on ramping up European sales, NeuroWave isn’t yet ready to detail its plans for commercializing the NeuroFAST device in the United States, Schmidt said.
The 510(k) clearance from the FDA is a major milestone for NeuroWave. The company has been developing its brain-monitoring devices since 2003 when it licensed the technology from co-inventor and now NeuroWave president, Tatjana Zikov.
NeuroWave was spun off in 2008 from Cleveland Medical Devices, which was founded by Schmidt. CleveMed develops biomedical signal processing and instrumentation devices for sleep and movement disorders, like Parkinson’s.
So far, NeuroWave has used federal grants and contracts, and at least one Ohio grant to develop its brain monitoring technologies — and not a single dollar from outside investors.
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).
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