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Neuralink did not respond to a request for comment about whether it had fixed any of the problems identified by the FDA. The company has said it goes above and beyond existing regulations in its ...
A U.S. lawmaker involved in health policy has asked the Food and Drug Administration why it did not inspect Elon Musk's Neuralink before allowing the brain implant company to test its device in ...
Neuralink did not respond to questions about the FDA visit. The FDA has not issued its designation indicating the severity of problems found in the inspection, according to the agency's database.
Neuralink received FDA approval for human clinical trials in May 2023. [90] The FDA had rejected a 2022 application to pursue human clinical trials, citing "major safety concerns involving the device's lithium battery; the potential for the implant's tiny wires to migrate to other areas of the brain; and questions over whether and how the ...
Elon Reeve Musk (/ ˈ iː l ɒ n m ʌ s k /; born June 28, 1971) is a businessman known for his key roles in the space company SpaceX and the automotive company Tesla, Inc. He is also known for his ownership of X Corp. (the company that operates the social media platform X, formerly Twitter), and his role in the founding of the Boring Company, xAI, Neuralink, and OpenAI.
Noland Arbaugh (born 1993 or 1994) is an American quadriplegic known for being the first human recipient of Neuralink's brain-computer interface (BCI) implant. [1] He gained attention for his use of the device to regain digital autonomy after a spinal cord injury left him paralyzed.
The FDA approval "represents an important first step that will one day allow our technology to help many people," Neuralink said in a tweet on Thursday, without disclosing details of the planned ...
Neuralink, the neurotech startup co-founded by Elon Musk, announced Thursday it has received approval from the Food and Drug Administration to conduct its first in-human clinical study.