FDA Gives Clearance for BrainScope’s Ahead 100 System

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. 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.

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