NordicNeuroLab receives FDA clearance for fMRI system

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The FDA has granted 510(k) approval to NordicNeuroLab for its functional MRI (fMRI) hardware system.

The Bergen, Norway-based company said its fMRI hardware system is a stimulus presentation and response collection system intended to be used by trained professionals to facilitate auditory and visual stimulation to be used in fMRI based on bold contrast.

The FDA approval letter said the system’s intended use is to support fMRI studies and to present the stimuli necessary to provoke physiological processes in the brain.