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.

FDA-Cleared BrainScope One (Medical Device News Magazine)BrainScope states 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.