Neuralink’s chips cannot be tested on humans for now
On numerous occasions, Elon Musk has predicted that his medical device company, Neuralik, will begin testing a revolutionary brain implant that will will treat conditions such as blindness and paralysis.However, this entity did not apply for permission from the U.S. Food and Drug Administration (FDA) until early 2022, which was ultimately rejected.
The denial was related to the incorporation of a lithium battery, the possibility of the implant’s wires migrating to other areas of the brain, or whether the device might damage brain tissue; but a year later, Neuralink is working on such bugs. to apply to the FDA for a human trial test.
Reuters notes that “Neuralink has not disclosed details of its application for a trial, the FDA rejection or the extent of the agency’s concerns. As a private company, it is not required to disclose such regulatory interactions to investors.”
Rejection increases the difficulty of applications to pass the test, in addition, companies that obtain a certificate of evidence often conduct two rounds before seeking FDA approval to market a device.
CHRONOLOGY: Elon Musk missed deadlines to get approval.
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– July 2019: Neuralink’s goal is to receive regulatory approval for brain implant trials by the end of 2020.
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– February 2021: Supposedly, the company had a close relationship with the FDA for testing by the end of 2021.
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– April 2022: Neuralink wants to get FDA approval to make the first human implant throughout 2022.
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– November 2022: Supposedly, the device was ready for testing, even though the FDA had not given any orders.
“Neuralink’s regulatory struggles stem in large part from its culture for setting targets for advances in extremely ambitious timelines and see regulators as obstacles to innovation,” explains Reuters.
Kip Ludwig (former director of the neural engineering program at the U.S. National Institutes of Health) states for the same media outlet that “Musk’s public statements and his well-known impatience represent a critical test for the FDA in balancing the demands for a speedy review with the diligence required to ensure safety and efficiency.”
FDA maintains high standards in research of all brain implants, and the federal government is also investigating the company’s treatment of its guinea pig animals.
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