GE AND THE NFL AWARD BRAINSCOPE WITH FURTHER FUNDING

BETHESDA, MD. July 23, 2015 – BrainScope Company, Inc. today announced that it has received an additional $500,000 award from GE and the National Football League (NFL) to further enhance its portable concussion assessment system, as one of six final winners of the GE NFL Head Health Challenge I. In February 2014, Brainscope was selected as one of the initial 16 recipients from more than 400 entries from 27 countries of the up to $10 million Challenge, which was created by GE and the NFL to award entrants for proposals focusing on “identifying breakthrough technologies and approaches that will improve the diagnosis and prognosis of mild traumatic brain injury (TBI).”

BRAINSCOPE’S AHEAD 200 DEVICE CLEARED BY FDA FOR ADJUNCTIVE ASSESSMENT OF TRAUMATIC BRAIN INJURY

BETHESDA, MD. May 18, 2015 – BrainScope Company, Inc. announced today that the United States Food and Drug Administration (FDA) has cleared the company’s Ahead 200 device. Using commercial smartphone hardware that leverages Google’s Android operating system, the Ahead 200 records and analyzes a patient’s electroencephalograph (EEG) using a custom sensor attached to the handheld to provide an interpretation of the structural condition of the patient’s brain after head injury. In late 2012, BrainScope announced that it had been awarded a $2.67 million contract by the United States Army for development of the Ahead 200, a smaller, more rugged and modernized version of its Ahead 100 traumatic brain injury assessment technology. Similar to the Ahead 100, which was cleared this past November, it is indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who are being considered for a head Computerized Tomography (CT) scan, but should not be used as a substitute for a CT scan. It is to be used on patients who sustained a closed head injury within 24 hours, clinically present as a mild traumatic brain injury (TBI), and are between the ages of 18-80 years.

BrainScope Announces Publication Demonstrating High Accuracy For Identification of Acute Stroke

BETHESDA, MD. January 6, 2015 – BrainScope Company, Inc. today announced the publication of an independent study that demonstrated the potential clinical utility of its Traumatic Brain Injury (TBI) technology to identify acute stroke in the hospital Emergency Department setting. The results of this study, “Identification of Acute Stroke Using Quantified Brain Electrical Activity” were published today in the peer-reviewed journal Academic Emergency Medicine authored by investigators from University Hospitals Case Medical Center, New York University School of Medicine, and The Johns Hopkins University School of Medicine. [...]

BRAINSCOPE ANNOUNCES FDA CLEARANCE OF AHEAD® 100 DEVICE FOR ADJUNCTIVE ASSESSMENT OF TRAUMATIC BRAIN INJURY

BETHESDA, MD. November 19, 2014 – BrainScope® Company, Inc. announced today that the United States Food and Drug Administration (FDA) has cleared the company’s Ahead® 100 device through the de novo classification process. The Ahead® 100 uses a patient’s electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient’s brain after head injury. It is indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who are being considered for a head Computerized Tomography (CT) scan, but should not be used as a substitute for a CT scan. It is to be used on patients who sustained a closed head injury within 24 hours, clinically present as a mild traumatic brain injury, and are between the ages of 18-80 years.

BRAINSCOPE AWARDED OVER $15.9 MILLION IN DEPARTMENT OF DEFENSE RESEARCH CONTRACTS

BETHESDA, MD. September 30, 2014 – BrainScope® Company, Inc. today announced that it has been awarded three contracts by the United States Department of Defense (DOD), both from the U.S. Army and Navy, for continued research and development of its Ahead® system for the assessment of Traumatic Brain Injury (TBI) and concussion. These three contracts combined are valued at $15.93 million. These newly awarded contracts will enable BrainScope to conduct further clinical studies and development of its TBI and concussion technology in hospital Emergency Departments and with university sports programs. From 2011 through 2013, BrainScope was awarded $11.27 million of DOD research contracts for the development of its TBI assessment technology, bringing the total awarded to date to $27.2 million. In addition, BrainScope has received significant funding from private investors to accelerate its development efforts.

BrainScope Collects $15.9M From Military for Traumatic Brain Injury Detection

BrainScope Co. has secured nearly $16 million in U.S. military contracts to advance handheld technology that could help clinicians diagnose concussions and other traumatic brain injuries sooner.

Traumatic brain injuries include structural injuries, such as a bruise or bleeding in the brain. They also include concussions, which are now diagnosed through cognitive and neurological assessments. Concussions, caused by a bump or jolt to the head, alter brain function.

BrainScope® Announces Publication of Independent, Prospective Validation Study Demonstrating High Accuracy For Identification of Traumatic Intracranial Hematomas

BETHESDA, MD. August 26, 2014 – BrainScope Company, Inc. today announced the publication of an independent, prospective validation study that demonstrated the potential clinical utility of its technology for the identification of acute traumatic intracranial hematomas in patients who present to hospital Emergency Departments. The results of this study, “Identification of Hematomas in Mild Traumatic Brain Injury Using an Index of Quantitative Brain Electrical Activity” appeared on-line ahead of print in the peer-reviewed Journal of Neurotrauma, authored by investigators from New York University School of Medicine and The Johns Hopkins University School of Medicine.

BrainScope Receives ISO 13485 Certification

BETHESDA, MD. April 14th, 2014 – BrainScope® Company, Inc., a medical neurotechnology company that is developing a new generation of hand-held, easy-to-use, non-invasive instruments designed as adjuncts to standard clinical practice assessment to aid medical professionals in rapidly and objectively assessing traumatic brain injury (TBI), today announced it has been successfully certified to ISO 13485:2003, the international standard for comprehensive quality management systems for design and manufacture of medical devices. ISO 13485:2003 is an international, globally recognized standard for establishing quality management systems that consistently meet customer and regulatory requirements for safe and effective medical device design and manufacturing. In addition, compliance with ISO 13485 is also a necessary step in achieving compliance with international regulatory requirements such as the CE Mark. BrainScope was awarded certification by BSI, one of the world's leading certification bodies.

BrainScope Receives GE NFL Head Health Challenge I Award

BETHESDA, MD. January 23rd, 2014 – BrainScope® Company, Inc. today announced that it has received an award from the GE and the National Football League (NFL) to further enhance its portable concussion assessment system by combining imaging biomarkers with its brainwave technology. In 2013, GE and the NFL created the $10 million Head Health Challenge I competition to award entrants for proposals focusing on “identifying breakthrough technologies and approaches that will improve the diagnosis and prognosis of mild traumatic brain injury (TBI).” The sixteen recipients of the award, including BrainScope, were announced today in New York.

BrainScope Announces Publication of Study Demonstrating High Accuracy for Identification of Traumatic Intracranial Hematomas

BETHESDA, MD. January 6th, 2014 – BrainScope® Company, Inc. today announced the publication of an independent study that demonstrated the potential clinical utility of its technology to identify traumatic intracranial hematomas in the hospital Emergency Department (ED). The results of this study, “Use of Brain Electrical Activity for the Identification of Hematomas in Mild Traumatic Brain Injury” were published in the December 15, 2013 issue of the peer-reviewed Journal of Neurotrauma. 

BrainScope Awarded Montgomery County Emerging Business of the Year

BETHESDA, MD. December 6th, 2012 – BrainScope® Company, Inc. announced today that it received the Verl Zanders Emerging Business of the Year Award by the Montgomery County Chamber of Commerce (MCCC) last evening at the 2012 MCCC Business Awards Dinner & Reception. The event was attended by over 700 business and government leaders. Among the seven awards presented during the evening were esteemed recipients such as J.W. Marriott, Jr. (Emeritus Business Leader), Booz Allen Hamilton (Prime Partner of the Year), and Lockheed Martin (Corporate Achievement).