Medical device startup NeuroWave Systems Inc. received regulatory clearance from the Food & 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 with patients who’ve experienced some sort of brain trauma, such as seizures. The system acquires and displays electroencephalographic signals — which are produced by neurons firing in the brain — obtained from noninvasive electrodes placed on a patient’s forehead, according to a statement from the company.
“It’s the first FDA-approved 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 anesthesia monitor, which is similar to the NeuroFAST system but operates on more-sophisticated algorithms, 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 U.S., Schmidt said.
510(k) clearance from the FDA has been a long time coming for NeuroWave. The company began developing its brain-monitoring devices in 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 penny from 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. of Norwood, Mass., according to Neurotech Business Report. Covidien plc acquired Aspect in November 2009 for $210 million.