The study will use a robot to surgically place a brain-computer interface (BCI) implant in a region of the brain that controls the intention to move, Neuralink said, adding that its initial goal is to enable people to control a computer cursor or keyboard using their thoughts alone.
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Officials with the Department of Agriculture (USDA) conducted a “focused” inspection in response to a complaint about the company’s handling of animal experiments.
The FDA nod “represents an important first step that will one day allow our technology to help many people,” Neuralink said in a tweet. It did not elaborate on the aims of the study, saying only that it was not recruiting yet and more details would be available soon.
The membership of the panel at Musk’s company, Neuralink, raises questions about potential violations of conflict-of-interest regulations aimed at protecting research integrity, a dozen animal-research and bioethics experts told Reuters. Neuralink is conducting animal experiments as it seeks regulatory approval for human trials of a brain chip intended to help paralyzed people type with their minds, among other ambitious goals.
Elon Musk’s brain implant company Neuralink has approached one of the biggest U.S. neurosurgery centers as a potential clinical trials partner as it prepares to test its devices on humans once regulators allow for it, according to six people familiar with the matter.
Neuralink, founded in 2016, has yet to receive FDA approval to test its brain chip in humans. Other implant makers have spent years or decades on research to secure U.S. regulatory approvals.
The company is developing brain chip interfaces that it says could help disabled patients to move and communicate again, with Musk adding it will also target restoring vision.
