3 articles
The German neurotech company becomes the first to receive FDA Breakthrough Device Designation for a brain-computer interface targeting motor recovery after stroke, with its closed-loop Brain Interchange system showing meaningful recovery in a Harborview Medical Center trial.
A Government Accountability Office report warns that the FDA has no framework for augmentation uses of brain-computer interfaces, even as military and commercial applications advance.
New guidance expands the 'general wellness' exemption for wearables and loosens oversight of AI clinical decision tools — with major implications for every company building consumer neurotechnology.
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