Clinical trial application by Elon Musk's brain implant company 'Neuralink' finally approved by FDA

Neuralink , a brain nerve implant development company co-founded by Elon Musk, has announced that it has received approval for human clinical trials from the US Food and Drug Administration (FDA).

Elon Musk's Neuralink reports FDA approval of an in-human clinical study - The Verge
https://www.theverge.com/2023/5/25/23738123/neuralink-elon-musk-human-trial-fda-approval

Elon Musk's Neuralink gets FDA approval for in-human study
https://www.cnbc.com/2023/05/25/elon-musks-neuralink-gets-fda-approval-for-in-human-study.html

Neuralink aims to connect the brain and the computer, and is developing a small device to be embedded in the brain. In 2020, we announced the brain nerve implant `` Link '' and the automatic surgery robot `` V2 '' aiming to treat paralysis due to neural paralysis, indicating that development is progressing steadily.

Neuralink CEO Elon Musk announces embedded chip ``Link'' & automatic surgery robot ``V2'' that connects the brain and AI - GIGAZINE

So far, Neuralink has conducted brain implant trials for pigs and monkeys, but Mr. Mask said in December 2022 that he would like to conduct a clinical trial on brain implant implantation in humans in the first half of 2023. He indicated that most of the necessary documents had been submitted to the FDA, and that the first human clinical trial would be conducted within six months.

Earon Mask's brain implant company 'Neuralink' hopes to embed a chip in the human brain in the first half of 2023-GIGAZINE

On the other hand, the FDA has rejected Neuralink's human clinical trial application in March 2023. Reasons for rejection included concerns over the use of lithium batteries to drive brain implants and concerns over whether the implant could be removed without damaging brain tissue.

FDA rejects clinical trial application by Earon Mask's brain implant company ``Neuralink'', concerns about implant lithium battery use and removal method - GIGAZINE

It was also reported that Neuralink was being investigated by the US government from the viewpoint ofrepeating illegal animal experiments and inappropriate management of devices removed from the brain .

However, on May 25, 2023 local time, Neuralink announced that ``We have received approval from the FDA for clinical trials in humans.'' Regarding approval from the FDA, Neuralink said, ``It is the result of a great job by the Neuralink team working closely with the FDA.(FDA approval) is an important first step for our technology to help many people.'' increase.

We are excited to share that we have received the FDA's approval to launch our first-in-human clinical study!

This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our…

— Neuralink (@neuralink) May 25, 2023

The scope of approval by the FDA and the recruitment requirements for participants were not announced at the time of writing the article, and Neuralink says, 'Details will be announced soon.'