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FDA Gives Clearance for BrainScope’s Ahead 100 System

by Kathy Jones on  November 25, 2014 at 9:01 PM Medical Gadgets   - G J E 4
The US Food and Drug Administration revealed that it has given a de novo clearance to Bethesda, Maryland-based company BrainScope for its Ahead 100 EEG-based system that can be used to determine which patients should be receiving a CT scan of the brain following an injury to the head.
 FDA Gives Clearance for BrainScope’s Ahead 100 System
FDA Gives Clearance for BrainScope’s Ahead 100 System
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The Ahead 100 device makes use of a database of EEG readings of patients who suffered brain injuries coming through emergency rooms and used it to create markers for a template that is matched with a patient's EEG graph in order to identify signs of serious brain injury.

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BrainScope revealed that it has received support from the US Department of Defense which had awarded it three contracts worth $15.93 million for further research and development of the system.

"FDA clearance of our Ahead 100 represents a major achievement in BrainScope's mission to create an objective, non-invasive, patient-friendly assessment device for rapid and easy use in emergency settings", Michael Singer, President and CEO of BrainScope, said.



Source: Medindia
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