WASHINGTON, Aug. 11 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:
"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 CEO Michael Singer. "We are working hard to develop this next generation technology to provide a reliable, rapid and objective adjunctive assessment of potential TBI for use in triaging patients, particularly in the military where the need is so high."
BrainScope's novel application of advanced mathematics and miniaturized hardware is designed to bridge the limitations of traditional EEG tools, which are bulky, expensive, and require expert data interpretation, to provide easy-to-use, non-invasive and timely tools that can assist with an initial assessment of brain function as well as provide adjunctive assessment across the brain care path.
Backed by Revolution LLC (the investment arm of AOL co-founder Steve Case), ZG Ventures and Alafi Capital, BrainScope is a health technology company that is developing a new generation of hand-held, simple-to-use, non-invasive instruments designed to aid medical professionals in rapidly, accurately, and objectively assessing brain function at the initial point of care. Initially, BrainScope has focused its research and development efforts on optimizing analysis of brain electrical signals to enhance detection and assessment of changes in brain function.
BrainScope's future products could eventually be used for assessment of suspected TBI in soldiers, athletes and accident victims.
Additionally, BrainScope announced the launch of a website, www.brainscope.com, where more information can be found about the company and its technologies.
BrainScope Company, Inc is a privately held medical neurotechnology company developing a new generation of portable, simple-to-use, non-invasive instruments to rapidly, and objectively assess brain function at the initial point of care. The portability and ease-of-use of these tools in development could aid United States military Health Service Support personnel in promptly diagnosing Traumatic Brain Injuries that require rest and/or other treatment and removal from environments at risk for repeat brain injury. The company's initial focus is the development of a device for military use, to aid in detection and assessment of Traumatic Brain Injury (including Severe Traumatic Brain Injury, Moderate Traumatic Brain Injury and Mild Traumatic Brain Injury/Concussion, all referred to as "TBI") using an objective scale.
-- 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
SOURCE BrainScope Company, Inc