Neuralink Gets FDA Approval for Human Trials of Brain Implant

Neuralink has received approval from the US FDA (Food and Drug Administration) to administer human trials of brain implants. Neuralink is a brain implant company by Elon Musk and it achieved a critical milestone despite the prior struggles.

Elon Musk had predicted human trials 4 times since 2019. He explained that Neuralink would begin human trials for a brain implant in order to treat conditions such as paralysis and blindness.

https://twitter.com/neuralink/status/1661857379460468736

The 2016 company sought FDA approval in early 2022 only, and the application was rejected according to the current and former employees.

According to the staff, Neuralink had received various issues from the FDA that needed to be addressed before approval of human trials. The lithium battery of the device, and potential for implant wires to migrate inside the brain, and the difficulty of properly removing the device without injuring brain tissue were the main problems.

https://twitter.com/elonmusk/status/1661897511337082880

The FDA's approval on Thursday comes as US senators are pressing regulators to look into whether the composition of a panel in charge of Neuralink's animal testing was a factor in the company's hurried and flawed trials.