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:6/24/2016)... ... June 24, 2016 , ... A recent article ... people are unfamiliar with. The article goes on to state that individuals are now ... of these less common operations such as calf and cheek reduction. The Los Angeles ...
(Date:6/24/2016)... ... June 24, 2016 , ... June 19, 2016 is World ... with chronic pain and the benefits of holistic treatments, Serenity Recovery Center ... with Sickle Cell Disease. , Sickle Cell Disease (SCD) is a disorder of the ...
(Date:6/24/2016)... ... June 24, 2016 , ... The ... in Dallas that it will receive two significant new grants to support its ... PHA marked its 25th anniversary by recognizing patients, medical professionals and scientists for ...
(Date:6/24/2016)... ... June 24, 2016 , ... Dr. Amanda Cheng, an ... Dr. Cheng has extensive experience with all areas of orthodontics, including robotic Suresmile ... orthodontics. , Micro-osteoperforation is a revolutionary adjunct to orthodontic treatment. It can ...
(Date:6/24/2016)... ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, ... minimum wage raise to $12 an hour by 2020 and then adjusting it yearly to ... value of the minimum wage, assure the wage floor does not erode again, and make ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , , , WHEN: ... , , , , LOCATION: , , , Online, with ... , EXPERT PANELISTS:  , , , Frost & Sullivan,s Global Vice ... Senior Industry Analyst, Divyaa Ravishankar and Unmesh Lal, Program Manager , ... industry is witnessing an exceptional era. Several new demand spaces, such ...
(Date:6/23/2016)... , June 23, 2016 ... Oticon , industry leaders in advanced ... launch of Oticon Opn ™, the world,s first ... of possibilities for IoT devices.      (Photo: ... Oticon introduces a number of ,world firsts,: ...
(Date:6/23/2016)... 23, 2016 Research and Markets ... Volumes: Global Analysis (United States, China, Japan, Brazil, United ... to their offering. ... healthcare business planners, provides surgical procedure volume data in ... with an in-depth analysis of growth drivers and inhibitors, ...
Breaking Medicine Technology: