Neuralink, Elon Musk’s brain implant company, announced Thursday night that its first human trial has been approved by the Food and Drug Administration.
“This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people,” the company tweeted.
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We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!
— Neuralink (@neuralink) May 25, 2023
This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our…
Neuralink scientists are aiming for a brain-computer interface by developing technology for brain implants, showing promise as a mechanism to fix various forms of paralysis and other neurological disorders.
In March, employees from Neuralink told Reuters that its application for human trials was rejected by the FDA due to myriad safety concerns, including the use of lithium batteries in the brain. Neuralink employees shared that the FDA rejection also questioned how the device would be extracted from the patient “without damaging brain tissue.”
Animal testing trails at Neuralink have also come under scrutiny for conflicts of interest after 19 members of the company’s 22-person animal research oversight board were employees of Neuralink.
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The FDA has not released information on Neuralink’s trial, and Neuralink is not obligated to provide more information due to its status as a private company.
Neuralink’s announcement said more information about participating in clinical trials would be forthcoming.