Strong Utility of BrainScope’s Brain Function Index for Head Injury Assessment Demonstrated in Validation Trial

FDA-Cleared BrainScope One Provides Proprietary, Objective EEG-Based Biomarker for Brain Injury, Including Concussion

BETHESDA, MD. June 14, 2017 – BrainScope Company, Inc. today announced a publication describing  that its EEG-based Brain Function Index (BFI) was demonstrated to have a significant relationship with the severity of functional impairment in mild head injured patients in a large (720 patient) multisite independent validation trial. BrainScope includes the BFI as a core component of its recently FDA-cleared BrainScope One product, which provides EEG and other information presented as a comprehensive panel on a handheld device for assessment of the full spectrum of traumatic brain injury.

Published online in the peer-reviewed Journal of Neurotrauma in an article entitled “A brain electrical activity (EEG) based biomarker of functional impairment in traumatic head injury: a multisite validation trial”, the findings support the BFI as a quantitative biomarker of brain function impairment, which scaled with severity of impairment in mild brain injury patients.

One-Third Potential Reduction in Unnecessary Head CT Scans Demonstrated in BrainScope One Study

Over 1 Million CT Scans Could Be Eliminated Annually in the U.S. by Incorporating BrainScope One into Standard Clinical Practice

BETHESDA, MD. June 1, 2017 – BrainScope Company, Inc. today announced a publication describing the use of its flagship product, BrainScope One, in an independent clinical trial demonstrating the potential reduction of one-third (33.3%) of unnecessary computed tomography (CT) scans of mildly presenting head injured patients in hospital emergency rooms (ERs).  The study entitled “Referrals for CT scans in mild TBI patients can be aided by the use of a brain electrical activity biomarker” was published online in the peer-reviewed American Journal of Emergency Medicine.

According to recent publications, approximately five million patients are seen in U.S. hospital ERs each year with closed head injuries, and millions more do not seek evaluation. The vast majority (>80%) of these patients receive a CT scan, of which over 90% are CT negative for structural brain injury, creating needless radiation exposure to patients.

Multi-Year Study Using BrainScope's Brain Function Index Suggests Compelling Utility as an Objective Biomarker for Concussion

BETHESDA, MD. May 23, 2017 – BrainScope Company, Inc. today announced the results of a study spanning over six years demonstrating that sports-related concussions can be objectively assessed using BrainScope’s proprietary electroencephalography (EEG) based Brain Function Index (BFI). Published in the peer-reviewed Journal of Head Trauma Rehabilitation, the study entitled “The Use of an Electrophysiological Brain Function Index in the Evaluation of Concussed Athletes” was conducted at 14 colleges and high schools, and funded in part through an award received under the NFL-GE Head Health Challenge I. In the study, 354 male contact sports athletes, 110 of whom sustained a concussion, were evaluated with results demonstrating that concussive injury significantly affected brain function, which was reflected in the BFI of the concussed athletes.  

BrainScope’s BFI, derived from characteristics of brain electrical activity that most closely reflect the physiology of concussion, was found to show highly significant differences between concussed athletes at the time of injury compared with non-injured athletes. Furthermore, at both pre-season baseline and 45 days following the injury, concussed athletes and the non-injured control group exhibited equivalent BFI scores, suggesting that the BFI can potentially provide an objective marker of concussive injury and recovery over time.  

The Centers for Disease Control and Prevention estimates that there are up to 3.8 million sports and recreation related concussions in the United States each year. Further, a 2014 JAMA publication reported head injury related hospital emergency room (ER) visits have increased...

BrainScope One Revolutionizes Brain Injury Assessment for Urgent Care Clinics

BrainScope to Showcase New-to-Market Medical Technology at
Momentum 2017: UCAOA Urgent Care Convention and Expo

Bethesda, MD – BrainScope Company, Inc. today announced it will unveil its new FDA-cleared, objective comprehensive head injury assessment device, BrainScope One, at Momentum 2017: UCAOA Urgent Care Convention and Expo from April 30 to May 3 at the Gaylord Resort and Convention Center in National Harbor, Maryland.

BrainScope One is a revolutionary medical technology that gives urgent care physicians and staff greater assurance to objectively assess the full spectrum of brain injury, including concussion. This handheld, easy-to-use product was recently rebranded by the company from the Ahead 300 to BrainScope One.

BrainScope Biomarker Adds Significant Prognostic Accuracy for Rapid Assessment of Traumatic Brain Injury

Peer-Reviewed Publication Demonstrates BrainScope’s Ahead 300 Significantly Improves Prediction of TBI Beyond Standard Clinical Risk Factors Used Today

BETHESDA, MD. February 27, 2017 – BrainScope Company, Inc. today announced a publication demonstrating that prediction of a CT positive traumatic brain injury (TBI) is significantly improved when the electroencephalography (EEG) based biomarker from its Ahead 300 is used in addition to the most commonly considered predictive risk factor, Loss of Consciousness (LOC). The results of this study entitled “Increased prognostic accuracy of TBI when a brain electrical activity biomarker is added to Loss of Consciousness (LOC),” were published in the peer-reviewed American Journal of Emergency Medicine. Results of this study show an 83% improvement in the prediction of TBI using the Ahead 300 compared to that obtained using a history of LOC alone or LOC plus traumatic amnesia, the two most commonly used clinical diagnostic indicators for TBI. 

BrainScope Announces Publication Demonstrating Extremely High Accuracy of the Ahead 300 for Identification of Traumatic Brain Injury in a Large Prospective Validation Study

Likelihood of CT+ vs. CT- Is One Component of the Ahead 300’s Configurable Panel of Capabilities for Mild Head Injury Assessment

BETHESDA, MD. February 16, 2017 – BrainScope Company, Inc. today announced a publication describing an independent clinical trial of 720 patients conducted in 11 U.S. Emergency Departments (EDs), validating the clinical efficacy of its Ahead 300 technology for the identification of Traumatic Brain Injury (TBI) in mildly presenting head injured patients.  The results of this validation trial, “Emergency Department triage of traumatic head injury using brain electrical activity biomarkers: a multisite prospective observational validation trial” are published online in the peer-reviewed journal Academic Emergency Medicine.

NFL: Advancing Concussion Diagnosis

In 2013, GE and the NFL teamed up to launch the GE-NFL Head Health Initiative, a four-year, $60 million collaboration to accelerate diagnosis and improve treatment for traumatic brain injury.

The initiative’s three-part Head Health Challenge open innovation program allocated $20 million for awarding grants to scientists, academics, entrepreneurs and other experts with leading ideas.

BrainScope used support from the Head Health Challenge to develop a new hand-held device that also has the potential to transform front-line care of head injuries.

BrainScope’s Ahead 300 headset and smartphone uses “sophisticated algorithms” to analyze patients with head injuries. It’s a quick test that is intended to provide “a rapid, objective assessment of the likelihood of the presence of traumatic brain injury (TBI) in patients who present with mild symptoms at the point of care.”

It was built in part through grant support from the GE-NFL Head Health Challenge. The U.S. Department of Defense also collaborated on the project.

In September 2016, the U.S. Food and Drug Administration gave the green light to BrainScope to begin marketing the Ahead 300.


Source: NFL Play Smart Play Safe (Click here to see NFL video with BrainScope)

BrainScope Launches the Ahead 300 for Objective Assessment of Mild Head Injury, Including Concussion

Ahead 300 Offers Objective, Configurable Panel of Capabilities at the Point of Care

Company's First Commercial Product to Ship in Q1

BETHESDA, MD January 5, 2017 – BrainScope Company, Inc. announced today the market release of its flagship Ahead 300 product, and will initiate a limited launch to a select group of thought leadersthrough its Centers of Excellence program later in the first quarter. These institutions will represent a cross-section of market segments including Urgent Care Clinics, Concussion Clinics, Emergency Medicine Departments, and University and Professional Sports. BrainScope will also be selling the Ahead 300 to various branches of the U.S. military and government.

NFL: New Handheld Device To Transform Front Line Care of Head Injuries

DISCLAIMER: The Ahead 300 is intended to be used in Emergency Departments, Urgent Care Centers, Clinics and other environments where trained medical professionals and practitioners practice medicine under the direction of a physician.

BrainScope Announces FDA Clearance of the First Handheld Medical Device for Assessment of the Full Spectrum of Traumatic Brain Injury

Panel of Multi-Modal Capabilities Will Aid Physicians
With Their Clinical Diagnosis of Head-Injured Patients

Company's First Commercial Product, Ahead 300, To Be Introduced in Coming Months


BETHESDA, MD. September 26, 2016 – BrainScope Company, Inc. announced today that the United States Food and Drug Administration (FDA) has cleared the company to market the Ahead 300, its most advanced medical device for use in assessing traumatic brain injury (TBI). Developed in partnership with the U.S. Department of Defense, the Ahead 300 provides a multi-modal device of clinically relevant measures, offering clinicians a comprehensive panel of data to assist in their diagnosis of the full spectrum of TBI, including concussion. The Ahead 300 represents an evolution from the three BrainScope products that have previously received FDA clearance, and with its substantial additional capabilities, will be the first product the company will sell commercially.

Brainscope Appoints Medical Device Industry Veteran Andrew Holman as Chief Commercial Officer

BETHESDA, MD - July 21, 2016 – BrainScope Company, Inc., a privately held neurotechnology company focusing on traumatic brain injury (TBI) and concussion assessment, announced today the appointment of Andrew Holman as Chief Commercial Officer. With over 20 years’ experience in sales and marketing in top echelon medical device companies, Holman will lead the commercialization efforts for BrainScope as it approaches the anticipated launch of its first product.

Holman most recently served as President of Corporate Development for Greatbatch, Inc., with prior roles as Chief Commercial Officer and Executive Vice President of Global Sales and Marketing.  During Holman’s tenure, Greatbatch exceeded market growth and completed a successful merger with Lake Region Medical, creating the largest medical device outsourcing organization in the world, now known as Integer Holdings Corporation.

Is This the Diagnostic Tool We’ve Been Waiting for in Concussion Testing?

A startup says its technology can serve as an objective concussion test. The challenge is convincing people it works.

By Mike Orcutt  MIT Technology Review - Biomedical

Concussion diagnosis is a notoriously tricky science.

Even if an assessment test on the sideline of a football or soccer field deems you to be concussion-free after a blow to the head, that doesn’t necessarily mean you didn’t suffer one, says Michael Singer, CEO of BrainScope, a Bethesda, Maryland-based company that has developed a new technology for detecting signs of a concussion in a person’s brain waves and has raised approximately


BETHESDA, MD – May 12, 2016 – BrainScope Company, Inc., a privately held neurotechnology company with an initial focus on traumatic brain injury (TBI) and concussion assessment, announced today that it received the Emerging Firm of the Year – Life Science Company Award by the Tech Council of Maryland (TCM). 

The award was presented Wednesday at TCM’s 28th Annual Industry Awards Celebration Dinner & Reception. The awards dinner is attended by over 800 executives from the life science and technology communities, and is Maryland’s largest and most prestigious award ceremony of its kind.  The criteria by which the award was judged included...


Dallas Hack, M.D., Col. (Ret.) and Geoffrey Ling, M.D., Ph.D., Col. (Ret.) Join BrainScope’s Scientific Advisory Board

 Bethesda, MD – April 19, 2016 – BrainScope Company, Inc., a privately held neurotechnology company with an initial focus on traumatic brain injury (TBI) and concussion assessment announced today that Dallas Hack, M.D., Col. (Ret.) and Geoffrey Ling, M.D., Ph.D., Col. (Ret.) have joined BrainScope’s Scientific Advisory Board.


“We are deeply honored to have both Dr. Hack and Dr. Ling join our Scientific Advisory Board.  Their expertise in traumatic brain injury and concussion is unparalleled in the field, and we look forward to their important contributions to help foster the development of BrainScope’s objective medical devices for assessment across the spectrum of TBI,” stated Michael Singer, CEO of BrainScope.

BrainScope’s Objective Concussion Assessment Technology Showcased at NFL Annual Meeting

Boca Raton, FL. – March 22, 2016 – BrainScope Company Inc., a privately held neurotechnology company with an initial focus on traumatic brain injury (TBI) and concussion assessment, was one of a handful of companies featured at the NFL Annual Meeting today in Boca Raton, Fla. 

BrainScope’s technology appeared in the NFL’s “Vision 20/20 Tech Lab” along with a collection of new technologies that are helping to enhance the game of football for the players, coaches and fans across all levels of football.  

This brain-scanning headset knows when you have a concussion

Chris Weller

Super Bowl 50 is here, which means athletes will be trying harder than ever to deliver big hits.

A new medical device designed to identify traumatic brain injury (TBI) might not be far behind.

BrainScope is a one-two punch headset and mobile app that quickly and easily allows clinicians to determine whether patients have sustained a TBI.

It follows a growing body of research that tries to understand what head injuries look like and, more importantly, what clinicians can do about them so people stay safe.

Michael Singer, BrainScope's CEO, says many of the current techniques for evaluating someone's level of injury are flawed because they rely solely on symptoms.

If someone sustains a nasty hit, for example, they may complain about head pain — or they might not.

In the NFL, athletes are only required to take a baseline exam at the beginning of the season, called the ImPACT test. If they suffer a head injury, they take the test again to check for any fall off in their score. But even this standardized test has been found to yield false positives.

BrainScope cuts through that unreliable self-reported data to ...

Keep reading in TECH INSIDER »



Super Bowl 50: amid NFL's golden era, hints of a sweeping change


The Super Bowl shows the NFL is more popular than ever, but the game could change in fundamental ways because of mounting public concerns over head injuries. 

By Gloria Goodale, Staff writer FEBRUARY 6, 2016

David J. Phillip/AP

David J. Phillip/AP

A BrainScope device is displayed before an NFL health and safety news conference Thursday in San Francisco. The device can be used to help diagnose traumatic brain injuries. (AP Photo/ DAVID J. PHILLIP/AP

LOS ANGELES — National Football League news this week told two dramatically different stories.

On one hand, there was the run-up to the Super Bowl, with all the anticipation and intrigue around whether the Denver Broncos can stop the juggernaut that is Cam Newton and the Carolina Panthers.

Last year’s ratings for the game – a record 114.4 million viewers – suggest the NFL has never been more popular.

Yet there was also the story of Kenny Stabler, the late Oakland Raiders quarterback who was revealed to have been diagnosed with CTE, the degenerative brain condition linked to many former professional football players.

The contrast was both poignant and apt, many say.

At a time when the NFL is the unrivaled king of American professional sports, concerns about ...


Keep reading in The Christian Science Monitor »


NFL Shows off Technologies to prevent concussions at Moscone Center

As part of the lead up to Super Bowl 50 the National Football League is showing off technologies it is funding to help prevent concussions among players.

By Eric Thomas

Thursday, February 04, 2016 11:47PM


As part of the lead up to Super Bowl 50 the National Football League is showing off technologies it is funding to help prevent concussions among players.

The show was timely. A week after the NFL released numbers showing an almost 60 percent increase in reported concussions last season, they brought in medical experts to talk about it

"I believe very strongly that the NFL has an unmatched opportunity and platform to affect change when it comes to player health," said Betsy Nabel, the NFL's chief medical advisor.

The league showed off companies funded by something called the Head Health Initiative. These firms have used grants to come up with projects to try and protect players from head injury, like a helmet that uses special shock absorbing structure to reduce brain-rattling force.

"When you hit it gives a little bit, like a car bumper and redistributes the force," said Samuel Brown, a neurologist.

One strange looking invention tries to diagnose concussions by examining brain waves.

"We look at particular patterns within the brain and then use a sophisticated algorithm to decipher those patterns," said Michael Singer, the CEO of Brainscope.

The NFL has fought a public relations battle, with players filing suit saying they weren't told about the dangers. And even a big screen movie, "Concussion," about the doctor who first recognized concussions could lead to a deadly condition called CTE.

Retired players worry about what will happen to them.

"As a linebacker if you don't know that you're hitting people with your head and there could be a problem, I mean you're kind of crazy if you don't realize that," said Chris Draft, former NFL linebacker.

Even if these products prove effective there's still one thing scientists will have to deal with, the fact that players get bigger and stronger every year.

NFL quickie concussion-check on horizon?

By Scott Ostler

February 4, 2016

Photo: Scott Ostler

Hi-tech brain scanner can help detect concussions in a jiffy.

Is the NFL really trying to make its game safer and protect its players?

That’s the message the league seemed to be sending out at Thursday’s Health and Safety press conference at the Super Bowl media headquarters.

A couple of the innovations that were showcased, that might eventually show up on NFL football fields:

--A waffle-type cushion installed under artificial turf, to absorb shock and lessen trauma to bodies and heads. The cushioning doesn’t change the feel of the turf for the players and doesn’t affect cutting, running and jumping.

A rep of the Detroit company, Viconic, says the stuff is ready to roll and his company is talking to a few NFL teams, but no deals have been struck. The rep said fewer than 10 percent of synthetic-turf fields have any kind of cushioning.

--A brain-scan device (see photo) that gives an instant read-out of various brain functions, providing the sideline doctor with a more measureable and definitive diagnosis of head trauma. Was Joe Quarterback concussed? Just check the read-out.

Michael Singer of BrainScope says the device will be submitted soon for FDA approval and potentially could be available for use in the NFL next season.

Is the league really charging into a new era of player safety? We’ll see.

Scott Ostler is a San Francisco Chronicle columnist. E-mail: Twitter: @scottostler


Scott Ostler

Sports Columnist