BrainScope(TM) Receives FDA Clearance for Portable ...( WASHINGTON Aug. 11 ...),Health

WASHINGTON, Aug. 11 /PRNewswire/ -- BrainScope Company, Inc today announced its first device, the ZOOM-100DC brain electrical activity data collection system, has been cleared for marketing by the U.S. Food and Drug Administration under section 510(k) of the FD&C Act. The ZOOM-100DC is an advanced 8-channel, portable, handheld electroencephalogram (EEG) device capable of recording and displaying EEG waveforms and providing conventional EEG measures displayed in tables.

The ZOOM-100DC is designed to be used at the initial point of care where traditional EEG tools are not readily available. The ZOOM-100DC is intended to monitor the state of the brain by acquisition and display of electroencephalogram (EEG) signals and by the calculation of standard quantitative EEG (qEEG) parameters. The ZOOM-100DC is a prescription use device.

The ZOOM-100DC device has the following functional features:

• Portable
• Battery Operated
• 8 single ended channels, (5 differential channels viewable concurrently)
• Automated artifact detection system ensures that EEG measures are derived from "clean" EEG signals.
• Spectral averaging and display of power spectra
• Conventional EEG measures displayed in Tables
• Pre-test electrode impedance check
• Ergonomic touch-screen user-interface with easy to read displays
• Raw EEG waveforms displayed in real-time and playback mode
• Compact Flash storage of digitized raw waveforms and processed results
  

"We are delighted that the ZOOM-100DC has received FDA marketing clearance. This is an important step for us as we further develop our technology platform to create a second device that is more sophisticated, robust, portable for adjunctive assessment of Traumatic Brain Injury (TBI)," said BrainScope
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