Neuralink receives FDA approval to begin human trials of its electronic version

Conversion Elon Musk’s FDA prediction had been off for about a month. After rejecting the company’s offer in March, The FDA approved the use of Neuralink to begin human testing of its Link brain-computer (BCI) model on Thursday.

Founded in 2016, Neuralink aims to commercialize BCIs in a variety of medical and therapeutic applications – from stroke and spinal cord injury (SCI) rehabilitation, to neural prosthetic controls, to energy “to go back in memory or download it in robots,” Neuralink CEO Elon Musk promised in 2020. BCIs translate analog electrical signals in your brain (monitoring them using hair-thin electrodes inserted into the gray matter) into digital 1’s and 0’s that computers can understand. Since a BCI requires surgery in the patient’s noggin, the FDA – which oversees such technologies – requires companies to carefully test safety before giving its approval for commercial use.

In March, the FDA rejected Neuralink’s application initiating human trials is said to be partly due to all test animals that die after the prototype BCI is implanted. According to internal documents obtained by Reuters in December, more than 1,500 animals were killed in the development of Neuralink BCI since 2018. US Department of Agriculture (USDA) Inspector General since he started research in that statement.

The FDA’s intransigence was also born out of concerns about the design and performance of the device when implanted in humans. “The agency’s main safety concerns were related to the device’s lithium battery; the ability of the implant’s tiny wires to migrate to other parts of the brain; and questions about how the device could be removed without damaging brain tissue,” current and former employees said. of Neuralink. he said Reuters in March.

Although Neuralink has received FDA approval to begin the study, the company is still not looking for volunteers. This is the result of the incredible work of the Neuralink team in collaboration with the FDA and represents an important step that will one day allow our technology to help more people,” Neuralink tweeted on Thursday. “Recruitment is not yet open for clinical trials.”

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