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ICE Neurosystems News

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June 9, 2021

TECHCRUNCH: ‘It’s almost like placing an IV’: Brain monitoring electrode receives FDA 510(k) clearance

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An FDA pathway that’s greased the gears for COVID-19 vaccines and drugs has paved the way for something else: a new take on electroencephalography (EEG), the established brain-monitoring technique in which metallic electrodes are placed on the scalp to measure the brain’s electrical activity. 

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May 17, 2021

iCE Neurosystems Announces FDA 510(k) Clearance for Brain Monitoring Devices Used in Critical Illness

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“While EEG has long been the gold standard for real-time monitoring of brain health, standard EEG requires specialized technical support and often provides poor quality data which profoundly limits the utility of this technique,” said Dr. Allen Waziri, neurological surgeon and CEO/Co-Founder of iCE Neurosystems. “iCE-SG Electrodes enable routine personnel at the bedside to record long-term, high-fidelity brain data that is optimized for immediate interpretation and clinical action.”

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D.C.’s iCE Neurosystems Inc. just got the green light to help doctors widely diagnose and stop brain injuries in hospitalized patients, following its emergency use in coronavirus cases during the pandemic and a recent funding round to support its expansion.

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