Neuralink, the brain-computer interface startup founded by tech billionaire Elon Musk, has said the US Food and Drug Administration has given permission for its first human clinical trials.

The clearance is a critical milestone in the development of its brain implant after Neuralink had struggled to obtain official approval for human brain-implant experimentation, despite Musk repeatedly claiming that it was close to begin testing on people for years. Last year in December during the company's latest show and tell, he said its N1 device could be inserted into humans in just six months.

Now, his promises might just be turning true. "We are excited to share that we have received the FDA's approval to launch our first-in-human clinical study!" the biz said on Twitter.

"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."

Without approval from regulators, Neuralink has only been able to test on animals. In video clips, the upstart claimed its brain chip helped train monkeys to perform simple computational tasks, such as playing Pong, moving a mouse cursor around, typing, and tracing numbers on screens.

For the brain upgrade, a small hole is drilled in the skull to insert the quarter-sized N1 sensor device. This chip has attached to it 1,024 electrodes that pierce the brain's gray matter to link with the biological neurons. The device uses those threads to receive electrical signals from brain, and relay them wirelesses to a computer nearby to analyze and control other devices and equipment. The N1 can be charged wirelessly via Bluetooth, too.

Neuralink is reportedly working on upgrading its hardware to use an Arm Cortex-M23 processor with 4,096 electrodes. The chip is fitted by a robot, or so that's the hoped.

It's unclear what experiments the outfit plans to run for its first in-human clinical trials. "Recruitment is not yet open for our clinical trial. We'll announce more information on this soon," it said.

Musk has said its initial focus will be to help paralyzed and blind patients walk and see, but that its long-term goal is to boost the cognitive power of humans so they aren't completely overpowered by AI. 

"What do we do if we have a digital superintelligence that is much smarter than any human?" he previously asked. Musk believes humans will need brain chips to expand their own abilities, and thought his idea wasn't as crazy as it sounded. "We are already cyborgs in a way that your phone and your computer are extensions of yourself," he added.

The upstart's development of its controversial brain chip hasn't gone smoothly. Last year, it was reported that it was under investigation for possible animal welfare violations. In March, a separate probe was launched over claims the biz might have illegally transported dangerous pathogens contained on the implants removed from dead animals it had tested on. ®

https://www.theregister.com//2023/05/26/neuralink_brain_implant_fda/