Navigation Links
BrainScope(TM) Receives FDA Clearance for Portable EEG Device
Date:8/11/2009

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 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.

About BrainScope(TM)

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.


'/>"/>
SOURCE BrainScope Company, Inc
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Integrated Medical Systems Receives $3.25 Million from the U.S. Army for Worlds First Suitcase Intensive Care Unit
2. AllMeds' EMR Receives CCHIT 2008 Certification Software Complies with 100 Percent of Certification Criteria
3. AlphaRx Receives China Patent on Its Drug Delivery Platform
4. Care to Care Receives Full URAC Health Utilization Management Accreditation
5. Covidien receives FDA clearance for its Puritan Bennett 840 ventilator system
6. Orphanage Receives Nearly $1 Million from Private Donor
7. Chesson Labs Liquid Bandage Product NUVADERM(TM) Receives FDA 510(k) Market Clearance
8. AccuVein Vein Illuminator Receives European CE Mark
9. CryoLife Receives CE Mark Approval for BioFoam(R) Hemostatic Technology
10. Watson Pharmaceuticals Receives FDA Approval for Generic Toprol XL(R) 25 MG and 50 MG
11. Savient Pharmaceuticals Receives Complete Response Letter from U.S. Food and Drug Administration for KRYSTEXXA(TM)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... ... February 12, 2016 , ... Each year, the American Physical ... in Anaheim, CA at the Anaheim Convention Center. Almost 10,000 physical therapists across the ... products in action, learn more about their chosen field and network with their colleagues. ...
(Date:2/12/2016)... ... 2016 , ... T.E.N., a technology and information security executive ... Awards 2016. Finalists and winners of the ISE® Awards for both Executive and ... Gala on March 15, 2016 at the Westin Peachtree Plaza, Atlanta. , ...
(Date:2/12/2016)... ... February 12, 2016 , ... Every winter, someone is ... winter the West Penn Burn Center, part of the Allegheny Health Network, ... to bring you the “Space Heaters Need Space” campaign. , “Space Heaters ...
(Date:2/12/2016)... TX (PRWEB) , ... February 12, 2016 , ... The ... and other communities across eastern Texas, is launching a cooperative charity drive with the ... families. , Serving more than 50,000 individuals and families in need, the Tarrant County ...
(Date:2/12/2016)... ... February 12, 2016 , ... Young ... area, celebrates the beginning of the latest charity campaign in their community enrichment ... art. Donations to this worthy cause are currently being accepted at: http://artexpressioninc.org/ ...
Breaking Medicine News(10 mins):
(Date:2/12/2016)... Carolina , 12 februari 2016 /PRNewswire/ ... (AAI/CML), een toonaangevende leverancier van productie en ... biotechnologische industrieën, kondigt vandaag een uitbreiding aan ... op haar locatie in Charleston, ... heeft geleid tot meerdere recente investeringen. ...
(Date:2/11/2016)... Feb. 11, 2016 The primary goal of ... adoption patterns on the usage of liquid biopsy. Key ... - Timeframe of liquid biopsy adoption amidst ... and Evs—by organization type - Sample inflow to conduct ... saliva, stool, serum, and so on. - Correlation analysis ...
(Date:2/11/2016)... 2016  Walgreens has committed to provide drug disposal ... Washington, D.C. as part of a program ... by shareholder advocacy organization As You Sow. Conrad ... people hold on to unneeded drugs because they lack easily ... --> Conrad MacKerron , Senior Vice President ...
Breaking Medicine Technology: