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BioWorld - Monday, March 9, 2026
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Home » FDA slams Neurofield for product misrepresentation and quality failures
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FDA slams Neurofield for product misrepresentation and quality failures

March 16, 2022
By Annette Boyle
The FDA unloaded on Neurofield Inc. for misbranding of its products, which are only approved as class II biofeedback devices, as neurostimulation and electroencephalogram (EEG) signal processing devices. The warning letter called on “Neurofield to cease any activities that result in the adulteration or misbranding of the Neurofield X3000/X3000 Plus, Neurofield Q21, Neurofield64 and Neurofield EEG.”
Medical technology Regulatory U.S. FDA

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