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EncephaloDynamics Receives FDA Clearance On Its Advanced EEG Sensor Array Cap – EEG-Now

Updated: May 21, 2018

Gainesville, FL – May 21, 2018 - EncephaloDynamics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has cleared the company to market EEG-Now™, an advanced product for EEG acquisition that takes only minutes to apply. The EEG-Now™ sensor array cap is designed for use in the ER, ICU and OR, to enable easy placement of an entire set of 21 EEG leads on the head in just a few minutes. The EEG-Now™ cap allows an EEG recording to be started in approximately 3 minutes, by any capable staff member in the ER, ICU or OR, resulting in an interpretable EEG at the point of care, regardless of time or location. This important diagnostic tool could expand the number of patients who benefit annually from an EEG, from the current 3 million to the more than 17 million patients who could benefit from an EEG each year but do not receive one because of the difficulty of setup and lack of trained EEG technicians.


“Utilizing EEG-Now™, healthcare facilities can quickly perform an EEG recording to help diagnose various kinds of brain injuries including altered mental status, seizures, concussion, traumatic brain injury, stroke, epilepsy and other neurological disorders,” stated J. Chris Sackellares, M.D., President of EncephaloDynamics, Inc. “Fast diagnosis and interventions are crucial when time loss equals brain loss. For example, in the case of stroke, 1.9 million neurons are lost each minute in which stroke is untreated. Because EEG setup time is reduced from 20 to 25 minutes to around 3 minutes, EEG-Now™ will help to improve patient outcomes and prevent avoidable deaths.”


With 30 years of EEG recording experience, co-inventor and EncephaloDynamics Chief Technical Officer, Scott Bearden, R. EEG/EP T., CNIM, CLTM, was motivated to bring to market an EEG sensor array cap that would be easy for any healthcare professional to use. “I spent a majority of my career frustrated because I knew the power of an EEG in diagnostics, but I was limited by current EEG acquisition technology.” Mr. Bearden added, “But today I am proud to be a part of solving that problem. Our technology opens this critical diagnostic tool to millions of patients who need an EEG but could not get one due to the length of the procedure of the lack or trained technicians.”


Because of its easy application, the EEG-Now™ technology may also in the future help patients at the location of injury – even on the football field. “The EEG is a sensitive marker for even mild disturbances in brain function. But, some people have a clinically normal EEG as early as 15 minutes after a concussion,” states Dr. Sackellares. “Using EEG-Now™ on the sideline immediately after a suspected concussion would beat the 15-minute limitation and help to accurately diagnose a concussion.”


EEG-Now™ will be available in Fall 2018. If you need more information or would like to receive production updates, contact Elena Fraser, Chief Operating Officer.




About EncephaloDynamics

Based in Gainesville, FL, EncephaloDynamics, Inc. is a neurotechnology device company guided by a fundamental mission: to expedite the diagnosis and treatment of brain injuries through revolutionary technologies that will help to improve patient outcomes and save lives. For more information, visit www.eeg-now.com.