Market Overview

BrainScope Receives FDA Clearance for Multi-Modal, Multi-Parameter Concussion Assessment


New Concussion-Specific FDA Labeling Adds to Existing BrainScope

Complements Multi-Modal Technology Platform and Extensive
Intellectual Property Portfolio To Address New Brain and Behavioral
Health Conditions

BrainScope®, a medical neuro-technology company focused on
concussion and mild traumatic brain injury (mTBI) assessment, announced
today that it has received FDA clearance to include additional language
in its product's Indications for Use (IFU), adding key terminology
related to "multi-modal, multi-parameter assessment" of "concussion" and
"mild Traumatic Brain Injury", as well as an expanded and clarified
overall IFU. In addition to being able to objectively and reliably
identify patients who may have a brain bleed using the product's
Structural Injury Classifier, BrainScope One uses the same
electroencephalogram (EEG) signal and other capabilities on the device
to objectively determine the likelihood of the presence and severity of
a concussion. All capabilities are summarized on a panel of multimodal,
multi-parameter results, greatly facilitating clinical concussion

This press release features multimedia. View the full release here:

The company's innovative BrainScope One system is an easy-to-use, non-invasive, hand-held platform t ...

The company's innovative BrainScope One system is an easy-to-use, non-invasive, hand-held platform that empowers physicians to make more accurate TBI assessments quickly and at the point-of-care. BrainScope's unique system leverages advanced digital signal processing, sophisticated algorithms and machine learning technologies to identify and evaluate key brain electrical activity biomarkers of TBI. BrainScope One also includes digitized versions of standard clinical assessments for milder forms of TBI known as concussion. (Photo: BrainScope Company Inc.)

"This additional FDA labeling for our product, BrainScope One,
recognizes the unique capabilities of our FDA-Cleared medical device
with labeling distinctively and specifically for this particular disease
state," stated Michael Singer, CEO of BrainScope. "Years ago in working
with our partner, the Department of Defense, we realized and learned
from them the importance of multi-modality and objectivity. Combining a
full range of concussion assessment capabilities on one handheld
platform provides the clinician a timely and easy-to-use tool for
collecting the objective data they need to facilitate their clinical
diagnosis, right then and there, for this debilitating brain disease

"Throughout most of 2018, we maintained an interactive dialogue with the
FDA on the labeling pertaining to our concussion assessment capabilities
and, as part of this ongoing discussion, we provided substantial data
for their consideration. This has led to BrainScope's 6th FDA
Clearance. This thorough vetting by the FDA shows our commitment to and
respect for adherence to the regulatory process as it relates to human
brain health, and in particular to the increasing national awareness of
the significant problem of concussion," added Singer.

BrainScope further announced that with a global patent portfolio of over
100 issued and pending patents, a substantial portion of these patents
relate specifically to multi-modality capabilities applicable to all
neurological conditions and disease states. "For over a decade, we have
created a platform comprised of unparalleled AI-based technology,
clinical evidence, peer-reviewed literature and regulatory knowledge,
supported by a vast IP portfolio. Given our success in developing BrainScope
for mTBI and concussion assessment, we have received
considerable interest from third-parties to further develop the
BrainScope multi-modal assessment platform for other neurological
disease states beyond concussion," stated Singer.

About BrainScope

BrainScope's mission is to revolutionize the rapid and objective
assessment of brain-related conditions, starting with concussion and
mild traumatic brain injury, utilizing multiple integrated assessment
capabilities, artificial intelligence (AI) and digitization within a
culture of quality, excellence and entrepreneurialism. The Company's
first product, BrainScope One (cleared as Ahead 300),
incorporates a multi-modal, multi-parameter panel of assessment
capabilities including EEG-based technology that is non-invasive for
mildly presenting head-injured patients, 18-85 years old, within 3 days
after injury and is not a replacement to CT scan. BrainScope's
technology platform integrates databases of thousands of brainwave
recordings with AI technology and miniaturized hardware and disposable
headset sensors, all of which are covered by an extensive intellectual
property portfolio of over 100 issued and pending patents globally.
BrainScope has received six FDA clearances and ISO 13485 Certification.
It has 25 peer-reviewed publications on its technology. Recent white
papers authored by third parties have shown the potential for BrainScope
 to decrease unnecessary head CT scans by one-third, to reduce
head injury referrals to hospital emergency departments by up to 75%,
and to reduce healthcare costs for payors and patients by over 30%.

BrainScope has partnered with the U.S. Department of Defense for the
development of its mTBI and concussion assessment technology, and BrainScope
 is currently being fielded by the U.S. military, both stateside
and internationally. BrainScope One is also being utilized
in a cross-section of market segments including: urgent care and
occupational health clinics; concussion clinics; hospital emergency
rooms; university sports and student health centers; professional
sports; and pharmaceutical clinical trials. BrainScope has been the
recipient of several prestigious awards, including the Frost & Sullivan
2017 Best Practices Award for New Product Innovation in the Traumatic
Brain Injury Assessment Solutions Market, was a two-time winner of the
GE-NFL Head Health Challenge, and has received two nominations for the
Prix Galien Best Medical Technology (2017 and 2018), regarded as the
equivalent of the Nobel Prize for medical devices. For more information,
please visit

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