Neuralink is recruiting patients for its first human clinical trial. We VERIFY the steps that companies have to take in order to do this.
. After a device is tested on people to make sure it’s safe and effective, the FDA reviews data in order to make a decision on whether or not to approve it.
“The FDA acknowledges and understands that Neuralink has announced that its investigational device exemption for its study of its implant/R1 robot was approved by the FDA and that it may now begin conducting human clinical trials for its device,” a spokesperson said. Neuralink is looking to recruit study participants who are at least 22 years old, and have either quadriplegia due to spinal cord injury or amyotrophic lateral sclerosis .
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