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news.Astro-Med has announced that its Grass Technologies Product Group, a provider of neurophysiological monitoring instruments and software, has received the FDA clearance to sell its Neurotrac III neuromonitoring software system.
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Grass Neurotrac III software has received the 510(k) clearance for the intended use of recording the electroencephalogram (EEG) and the computed EEG trends over extended periods of time so that trained healthcare professionals can observe long-term changes. The company will now begin to sell this existing product for new applications in continuous EEG monitoring.
In addition to displaying and recording the traditional EEG waveforms, the Neurotrac III software also computes and displays graphical trends of EEG features such as amplitude integrated EEG trend, frequency trends, and Burst-Suppression Patter trends which aid the physician in identifying changes in brain function over time. The displayed information allows a nurse or physician to intervene and modify treatment of the patient to improve neurological outcome, the company said.
Marco Mancini, grass technologies sales manager, said: The Neurotrac III will expand our markets from the traditional EEG and long term monitoring labs into the intensive care units and operating rooms of hospitals where monitoring brain activity is now considered as valuable as monitoring cardiac rhythm.