BETHESDA, Md.--(BUSINESS WIRE)--Apr 30, 2018--BrainScope announced today the release of a white paper authored by physicians at Washington University Barnes Jewish Medical Center in St. Louis, which demonstrated that the FDA-cleared BrainScope One had the potential to reduce the use of unnecessary head CT scans by one-third in a hospital Emergency Department setting.
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FDA-Cleared BrainScope One (Photo: Business Wire)
Today most patients seen in the emergency room with a suspected head injury receive a computed tomography (CT) scan of the head to detect brain tissue damage, or intracranial lesions, that may require treatment; however, the vast majority of these patients do not have detectable intracranial lesions visible on the CT scan. The availability of BrainScope One can help health care professionals determine the need for a CT scan and help prevent unnecessary neuroimaging and associated radiation exposure to patients.
Using data entered in BrainScope’s national Registry, the white paper authors compared 64 patients who were referred for CT scan following the traditional site referral pathway versus using the BrainScope One “Structural Injury Classifier” determination in guiding referral for CT scan. These patients were mildly-presenting (average GCS of 15), between the ages of 18 and 74 (an average age of 43 years), and assessed within three days of injury. The authors demonstrated that in a real-world Emergency Department setting, use of the BrainScope One device could have led to a significant reduction in head CT scanning of 33% in this patient group without incurring any false negative cases (100% sensitivity). These initial results in the hospital Emergency Department setting matched the overall CT referral rate reduction reported for the BrainScope’s FDA validation trial.
The paper’s lead author, Dr. Rosanne Naunheim, stated, “The use of such rapidly obtained, objective information has the potential to reassure ED physicians in making confident clinical decisions that their patients do not need a CT, and will go a long way toward decreasing unnecessary radiation and decreasing the cost of care.”
The white paper entitled “Potential Significant Reduction in Unnecessary CT Scans in Emergency Departments Using an FDA Cleared Medical Device for Brain Injury Assessment” can be found here: http://brainscope.com/media/2018/4/29/washington-university-emergency-department-white-paper.
For more information about the BrainScope technology, visit www.brainscope.com/products.
BrainScope Company, Inc. (“BrainScope”) is a medical neurotechnology company that is developing a new generation of handheld, easy-to-use, non-invasive devices designed to aid medical professionals in rapidly and objectively assessing various neurological conditions, beginning with traumatic brain injury (TBI), including concussion. The company’s first product introduced in 2017, BrainScope One (FDA cleared as Ahead 300), uses EEG-based technology that is non-invasive for mildly presenting patients 18-85 years old and within 3 days after head injury and is not a replacement to CT scan. BrainScope’s technology platform integrates databases of thousands of brainwave recordings with advanced digital signal processing, sophisticated algorithms, miniaturized hardware and disposable headset sensors, which are all covered by an extensive intellectual property portfolio of over 100 issued and pending patents. BrainScope has received four FDA clearances and ISO 13485:2003 Certification. BrainScope has partnered with the U.S. Department of Defense for the development of its TBI assessment technology, and was named both an original recipient and final awardee of the GE-NFL Head Health Challenge I. For more information, please visit www.brainscope.com.
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CONTACT: BrainScope Company, Inc.
Laurie Silver, 240-752-7680
KEYWORD: UNITED STATES NORTH AMERICA MARYLAND
INDUSTRY KEYWORD: PRACTICE MANAGEMENT HEALTH BIOTECHNOLOGY MEDICAL DEVICES FDA
SOURCE: BrainScope Company, Inc.
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PUB: 04/30/2018 06:00 AM/DISC: 04/30/2018 06:01 AM