The approval "represents an important first step that will one day allow our technology to help many people," Neuralink said in a tweet.
The company envisions using its microchips to treat conditions such as paralysis and blindness, and to help disabled people use computers and mobile technology.
The cosmetically invisible brain implants are designed to let users control their computers and mobile devices with their thoughts.
Neuralink has been seeking FDA approval since 2019, while FDA had pointed out several concerns that needed to be addressed before sanctioning human trials.
The company is still under federal investigation for alleged animal-welfare violations, amid internal staff allegations that animal testing is being rushed, resulting in unnecessary suffering and deaths.