Ceribell Neurology Review Software
Ceribell, Inc.The Ceribell Neurology Review Software is an AI-based tool designed to assist qualified clinicians in reviewing EEG recordings. It helps reduce artifact signals and automatically identifies sections of EEG that may represent epileptiform abnormalities, aiding in the assessment and diagnosis of neurological conditions.
Intended Use
The Ceribell Neurology Review Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices using scalp electrodes and to aid neurologists in the assessment of EEG.
Technology
The software includes an Artifact Reduction component that reduces artifact in EEG recordings without removing entire artifact signals and an Epileptiform Abnormality Detection component that marks sections of EEG related to epileptiform abnormalities to assist clinical practitioners. The technology analyzes EEG waveforms acquired from EEG devices.
Performance
Performance testing included validation of artifact reduction against a predicate artifact reduction algorithm using clinical datasets from three hospitals, demonstrating non-inferior signal-to-noise ratio improvement and waveform distortion. The epileptiform abnormality detection was validated on a large independent EEG dataset with expert neurologist-labeled reference standards, meeting acceptance criteria for positive percent agreement and false positive rates across age groups.
Predicate Devices
No predicate devices specified
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