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FDA clears NeuroWave's brain monitoring system

 
• By Madeleine Armstrong

NeuroWave Systems' NeuroFast NF-201 brain monitoring system has become the firm's first product to receive 510(k) clearance from the US FDA. The device is designed to evaluate brain function in patients in hospital operating rooms, emergency departments and intensive care units, via electrodes that are placed on the forehead. These measure real-time electroencephalogram (EEG) data from both hemispheres of the brain. The monitor is similar to NeuroWave's NeuroSense device, which it CE marked earlier this year (www.clinica.co.uk, 1 July 2010); however, NeuroSense has more sophisticated algorithms for automated EEG interpretation. The Cleveland Heights, Ohio firm said in an article in MedCity News that it has been concentrating on marketing NeuroSense in Europe, so is not ready to start selling NeuroFast in the US.

NeuroWave Systems' NeuroFast NF-201 brain monitoring system has become the firm's first product to receive 510(k) clearance from the US FDA. The device is designed to evaluate brain function in patients in hospital operating rooms, emergency departments and intensive care units, via electrodes that are placed on the forehead. These measure real-time electroencephalogram (EEG) data from both hemispheres of the brain. The monitor is similar to NeuroWave's NeuroSense device, which it CE marked earlier this year (www.clinica.co.uk, 1 July 2010); however, NeuroSense has more sophisticated algorithms for automated EEG interpretation. The Cleveland Heights, Ohio firm said in an article in MedCity News that it has been concentrating on marketing NeuroSense in Europe, so is not ready to start selling NeuroFast in the US.

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