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Using Commercial Smartphone Technology, Second-Generation System Offers Objective Assessment of Mildly-Presenting Head Trauma Patients
BETHESDA, Md.--(BUSINESS WIRE)--BrainScope Company, Inc. announced today that the United States Food and Drug Administration (FDA) has 510(k) 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.
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