FDA Denied Neuralink’s Request To Start Human Trials

According to foreign media reports, FDA has rejected Elon Musk-led Neuralink to start human trials. The company has yet to resolve the problems of implantable devices and other concerns. Neuralink’s documents show that it plans to obtain FDA approval for human testing by March 7 of this year, but employees of Neuralink said they are not confident about it. One employee even called it a gamble. The FDA rejected Neuralink’s request for human trials, listing dozens of “defects” that needed to be solved before Neuralink could implant their device in the brain. Some employees who have read FDA documents said the concerns are modest whilst others felt these are important concerns. For example, the FDA is particularly concerned about the safety of the rechargeable lithium battery carried by the implantable device, which can potentially damage the brain, and thought that the company needs to conduct animal experiments to prove that the battery functioned correctly. Another concern is the fine wire of the implantable device, which is thinner than a hair but may lead to inflammation, vascular rupture, and damage to brain function when implanted in the brain. Musk co-founded Neuralink with eight other scholars in 2016. In 2019, he said that the company’s goal is to launch human trials by the end of 2020, hoping to help patients with spinal cord injuries and dementia to regain the ability to move or communicate. With many issues to be resolved, unfortunately, the dateline for human trials keeps getting deferred.