Bloomberg reported on the twenty sixth (local time) that Neuralink, a brain-computer connection technology (BCI) company, has received approval from the US Food and Drug Administration (FDA) for human clinical trials.
In keeping with this, Neuralink said on Twitter on the twenty fifth, “Which means our technology has taken a crucial step forward that may sooner or later help many individuals.” “It’s the results of close collaboration with the FDA.” Nevertheless, it added that it has not yet began recruiting test subjects.
Neuralink is a BCI company founded by Elon Musk in 2016. It’s a technology that drills a hole within the human skull and inserts a chip connected to a pc in order that it might probably operate electronic products with only thoughts and overcome body paralysis or brain disease. is developing
The method was not smooth. Neuralink originally planned to receive FDA approval by the top of 2020, but was rejected after applying for human trials to the FDA early last 12 months. It is usually being investigated by the USDA for animal welfare violations and the Department of Transportation for allegations of transporting implants believed to have been contaminated by sick monkeys.
Within the meantime, US BCI startup Synchron is thought to have developed a brain implant that’s transplanted through blood vessels without brain surgery last month and successfully implanted it in seven patients. Also, a research team on the Technical University of Lausanne in Switzerland announced on the twenty fourth that they succeeded in getting a patient who was disabled from using the lower body because of a spinal cord injury to rise up and walk with BCI technology.
It’s an evaluation that the event release shouldn’t be imminent even when it has been approved by the FDA. “It took almost a 12 months for Synchron to receive FDA approval in July 2022 and implant the actual device,” said Christine Well, a professor of neurosurgery on the University of Colorado, who’s an FDA graduate. It’ll take 10 years,” he said.
“Anyway, this approval is an enormous turning point for Neuralink,” he said. “Future human trials will allow us to speed up device development with greater flexibility than previous trials.”
Reporter Lim Dae-jun ydj@aitimes.com
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