4 articles
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.
Multiple companies, including Elon Musk's Neuralink, are racing to bring brain-computer interface technology out of research labs and into commercial markets.
Kim Han-sol, a blind YouTuber with 1.68 million subscribers, has publicly applied for Neuralink's Blindsight clinical trial, bringing significant public attention to the experimental vision-restoring brain implant.
Chinese BCI company NeuroXess has surpassed human trial milestones, positioning itself as a direct competitor to Neuralink in the global neural interface market.
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