BRAIN SENTINEL, INC. SPC15-90045 SPEAC System Electrode Patch-SPC15-90045, EU

The Brain Sentinel® Seizure Detection and Warning System is an ambulatory systemdesigned to monitor and analyze electromyography (EMG) data to detect the onsetof a generalized tonic-clonic (GTC) seizure whether primary or focal onset withsecondary generalization and to provide a warning signal to alert caregivers that aseizure is occurring. The system records EMG data (24/7) and is available for analysisof other motor events.The Brain Sentinel Seizure Detection and Warning System is intended for monitoringadults with a history or significant risk of generalized tonic-clonic seizures in thehome or healthcare facilities, during the titration or withdrawal of anti-epileptic drugs,and for continuous monitoring, night time or any other time of day, of individuals dueto their history or risk of generalized tonic-clonic seizures and will withstand activitiesof daily living including showers and sleep. The Brain Sentinel Seizure Detection andWarning System is available by prescription only.