The US stops Musk in his conquest of our brains: for now, he will not be able to test the Neuralink chips in humans.
Neuralink hoped the FDA would clear human trials for its brain implant by March 7, 2023.
On numerous occasions, Elon Musk has predicted that his medical device company, Neuralik, will begin testing a revolutionary brain implant that will treat conditions such as blindness and paralysis, yet the entity did not seek permission from the Drug Administration and Food of the United States (FDA, for its acronym in English) until the beginning of 2022, which was finally rejected.
The denial related to the addition of a lithium battery, the possibility of implant wires migrating to other areas of the brain, or whether the device could damage brain tissue; but a year later, Neuralink works on those errors to ask the FDA for proof of human trials.
As reported by Reuters “The specifics of Neuralink’s test request, the FDA’s denial, or the scope of the agency’s concerns have not been made public. It is not necessary to report such regulatory interactions to investors as it is a private corporation.”
Rejection increases the difficulty of applications to approve the trial in addition, companies that obtain certification of the tests usually go through two rounds before seeking FDA approval to market a device.
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TIMELINE: Elon Musk missed deadlines to get approval
- February 2021: Supposedly, the company had a close relationship with the FDA to do the tests in late 2021.
- April 2022: Neuralink wants to get FDA approval to make the first human implant in 2022.
- November 2022: Supposedly, the device was ready for testing, despite the fact that the FDA had not given any order.
“Neuralink’s regulatory struggles stem largely from its culture of setting targets for progress under extremely ambitious time frames and viewing regulators as obstacles to innovation,” Reuters explains.
Kip Ludwig (former director of the neural engineering program at the National Institutes of Health of the United States) affirms for the same media outlet that “Musk’s public statements and his well-known impatience represent a critical test for the FDA when balancing the demands of a rapid review with the due diligence required to ensure safety and efficacy.
The FDA maintains high standards in the investigation of all brain implants, and the federal government is also investigating the company’s treatment of its animals which are guinea pigs.
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