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Diagnostic accuracy of microEEG®: A miniature, wireless EEG device

April, 2014

Diagnostic accuracy of microEEG®: A miniature, wireless EEG device: The results of a prospective clinical trial of microEEG® to measure its sensitivity and specificity compared to a “reference” EEG machine were published in the journal of Epilepsy and Behavior (link to full paper). The EEG recordings were acquired from Emergency Department (ED) patients with AMS, a population where the advantages of microEEG® are particularly valuable. Using the unblinded interpretation (abnormal or normal) of EEGs recorded from the reference system as a gold standard, the measured sensitivity and specificity of EEGs obtained from the microEEG® system did not differ significantly in either measurement condition including the use of unconventional electrodes with microEEG®. Thus, the diagnostic accuracy of microEEG® is comparable to that of the reference system in this clinical ED setting. View Manuscript

 

Effect of microEEG® on Clinical Management and Outcomes of Emergency Department Patients With Altered Mental Status

March, 2014

Effect of microEEG® on Clinical Management and Outcomes of Emergency Department Patients With Altered Mental Status: A randomized controlled (RCT). The RCT results of the work up of Emergency Department (ED)/Altered Mental Status (AMS)patients with and without microEEG® have been published in Academic Emergency Medicine Journal (link to full paper). A total of 149 patients were enrolled (76 control and 73 receiving microEEG®). Using microEEG® was associated with change in diagnostic work-up in 49% (95% CI = 38% to 60%) of cases and therapeutic plan in 42% (95% CI = 31% to 53%) of cases immediately after the release of the EEG results. Electroencephalograms (EEGs) obtained by microEEG® can affect diagnostic and therapeutic management of AMS patients in the ED. These findings paired with the high incidence of electroencephalographic abnormalities in AMS patients, further support the need to incorporate EEG in the work-up of these patients in the ED. View Manuscript

microEEG® use by bedside Neonatal ICU (NICU) staff

December, 2013

microEEG® use by bedside Neonatal ICU (NICU) staff: Few NICUs are equipped with EEG machines or staffed with specialized technologists who can properly apply EEG electrodes and provide a technically adequate study. The microEEG® system provided high quality continuous EEG recordings in the NICU performed by bedside staff. This approach was presented at the American Epilepsy Society Annual Meeting- December 2013- Washington D.C. View Presentation

The microEEG® system will be used to assess the effects of tDCS

January, 2013

The microEEG® system will be used to assess the effects of repeated sessions of Transcranial Direct Current Stimulation (tDCS) to the left dorsolateral prefrontal cortex on frequency of interictal discharges and seizure frequency on patients with temporal lobe epilepsy (TLE). The primary behavioral outcomes for this interventional study will be working memory and mood benefit. However, the microEEG® system will help determine if this form of non-invasive neuromodulation can be applied without worsening ictal or interictal activity in TLE patients. The two study sites are at New York University (NYU) Comprehensive Epilepsy Center and the Beth Israel Deaconess Medical Center/Harvard Medical School, Boston MA. The results of this study will have a significant clinical impact for the treatment of the cognitive and psychiatric comorbidities of patients with TLE.

microEEG® System cleared for commercial distribution

June, 2012

Bio-Signal Group announces that the U.S. Food and Drug Administration has cleared the Company’s microEEG® System for commercial distribution.

The microEEG® System selected for a Moderated Poster Presentation

May, 2012

The microEEG® System diagnostic utility in identifying aberrant electrographic categories in Emergency Department patients with Altered Mental Status, has been selected for a Moderated Poster Presentation at the SAEM 2012 Annual Meeting in Chicago on May 9-12. The abstract has been scheduled for presentation on Saturday, May 12, 1:00 – 2:00 PM.

The microEEG® System selected to represent the best research in the Emergency Medicine field

May, 2012

BSG’s clinical trial results on the use of the microEEG® System in the Emergency Department, has been selected for the Plenary Session at the Society of American Emergency Medicine (SAEM) in Chicago on May 9-12. This work has been selected over 1,100 abstracts to represent the best research in the Emergency Medicine field. The session is scheduled for presentation on Thursday, May 10, 4:30 – 6:00 PM

The microEEG® System is selected to ascertain subclinical seizures/seizure freedom

May, 2012

The microEEG® System is selected to ascertain subclinical seizures/seizure freedom in pediatric patients with cerebral malaria receiving enteral Levetiracetam (LVT). The unique features of the BSG’s system also allows for continuously monitoring 2-3 patients simultaneously in the compact area occupied by the Queen Elizabeth Center Hospital in Malawi. The two year study is funded by NINDS and affiliated with Michigan State University. View More

510(k) filed for the microEEG® System

September, 2011

BSG files FDA 510(k) Premarket Notification (application) for the microEEG® System.

Evaluation of the microEEG® System

August, 2011

TUV of North America Inc. has completed an evaluation of the microEEG® System to EMC and medical safety requirements and found it to be in compliance. View More