6 articles
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.
U: The Mind Company began taking orders for a consumer neuromodulation device on March 18, marketing bold clinical claims that have not appeared in peer-reviewed literature. An FDA submission is planned for 2027.
The agency's new policy ending the two-trial requirement was written for drugs, but brain implant makers watching Synchron, Neuralink, and Paradromics navigate FDA are asking whether the same logic could eventually ease their path.
In just nine months China has issued a national BCI blueprint, overtaken the United States in BCI patent filings, funnelled hundreds of millions into startups, and has just granted the world's first commercial implant approval.
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.
Seven Chinese government bodies have released guidelines establishing a roadmap for brain-computer interface development, with BCI procedures now receiving medical insurance reimbursement in parts of the country.
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