Elon Musk’s brain-implant company Neuralink announced on Thursday that it received the U.S. Food and Drug Administration’s (FDA) approval to conduct its first in-human clinical study.
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“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 technology to help many people.” tweeted the company. Tesla (NASDAQ:TSLA) CEO Musk retweeted the post, congratulating the team. Neuralink added that recruitment has not yet started for the clinical trial and the company will provide more information soon.
Founded in 2016, the Fremont, California-based neurotechnology company is developing implantable brain-computer interfaces (BCIs). The company aims to use these implants to help patients suffering from paralysis or degenerative diseases to communicate by controlling a computer or mobile device via brain signals.
Until now, Neuralink has conducted research only in animals and has faced many probes in this matter. For instance, the company is under investigation by the U.S. Department of Agriculture’s Office of Inspector General for potential animal-welfare violations.
As per a Reuters report in March 2023, Neuralink had previously sought FDA approval in early 2022, but the agency rejected the application, outlining “dozens” of issues that it was asked to address before human testing. Some of the concerns raised included the device’s lithium battery, the possibility of the implant’s tiny wires migrating to other areas of the brain, and the removal of the implant without damaging brain tissue.
