Elon Musk’s brain-chip firm says it has received approval from the US Food and Drugs Administration (FDA) to conduct its first tests on humans.
The billionaire’s Neuralink implant company wants to help restore people’s vision and mobility by connecting brains with computers.
It says it does not have immediate plans to start recruiting participants. Mr Musk’s previous ambitions to begin tests came to nothing.
The regulator itself is yet to comment.
An earlier bid by Neuralink to win FDA approval was rejected on safety grounds, according to a report in March by the Reuters news agency that cited multiple current and former employees.
Neuralink hopes to use its microchips to treat conditions such as paralysis and blindness, and to help certain disabled people use computers and mobile technology.
The chips – tested in monkeys – are designed to interpret signals produced in the brain and relay information to devices via Bluetooth.
Mr Musk has also previously suggested that the proposed technology could help ease concerns about humans being displaced by artificial intelligence.
Announcing Thursday’s news on Twitter, Neuralink talked of an “important first step that will one day allow our technology to help many people”.
The approval was “the result of incredible work by the Neuralink team in close collaboration with the FDA”, it said.
The firm promised more information “soon” on plans to sign up trial participants.
Its website promises that “safety, accessibility and reliability” are all priorities during its engineering process.
Experts have cautioned that Neuralink’s brain implants will require extensive testing to overcome technical and ethical challenges if they are to become widely available.
The company – co-founded by Mr Musk in 2016 – has repeatedly overestimated the speed at which it can execute its plans.
Its initial aim was to start planting chips in human brains in 2020 to honour a pledge made the year before. It later vowed to get started in 2022.