FDA clears Elon Musk’s brain implants for human trials

Elon Musk’s brain-implant company Neuralink announced yesterday it had been given the go-ahead by the US Food and Drug Administration (FDA) to begin its first in-human clinical study.

Neuralink used the Musk-owned platform Twitter to make the announcement [1], which comes after the company’s previous struggles to gain FDA approval.

Longevity.Technology: Last year, the FDA rejected Neuralink’s application over concerns about the safety of the experimental implant. Former Neuralink employees told Reuters the rejection was due to questions over the safety of the device’s lithium battery, the worry that the implant’s minute wires might potentially be able to migrate to other areas of the brain, and concerns over if – and how – the implant can be extricated without damaging tissue in the brain [2]. Musk has remained buoyantly optimistic about the device throughout, telling the world he feel comfortable implanting the chip into one of his children [3].

Although the new study is not yet recruiting, we would imagine the lure of being part of this futuretech will outweigh any safety concerns for many, and that Mr Musk will have no problem recruiting human guinea pigs volunteers.

FDA clears Elon Musk's brain implants for human trials

Neuralink 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.” [1]

Neuralink’s neural lace tech works by letting a sewing machine-like robot surgically insert a microchip inside specific areas of the brain. The tech removes a small chunk of the skull, connects the thread-like electrodes to target regions of the brain and sutures the hole, leaving only a scar.

Once the microchip is implanted, it acts as an intermediary, effectively translating the intricate electrical signals generated by the brain. It captures and interprets these signals, seamlessly transmitting the data to external computing devices using Bluetooth technology.

Neuralink has previously expressed the hope that this tech will help treat paralysis and blindness in humans and its chips have proved to be successful in primates, and the company showed in its video of a monkey playing Pong [4].

Musk has previously claimed that the implantation procedure will not require general anaesthesia and and will take less than an hour, comparing it to getting Lasik vision surgery, with patients going home the same day. He has expressed a hope that eventually the device will be commonplace, delivering music and content, instead of just a medical treatment.

It is also worth nothing that Neuralink was beaten to the punch by Utah-based biotech Blackrock Neurotech, which has already implanted its Neuroport Array chip into human brains more than 50 times. The Blackrock chip uses an array of 96 microneedles and can open over 600 channels of communication enabling individuals to control wheelchairs and robotic limbs, play computer games and discern feelings.

In addition, Synchron bagged FDA approval in July 2021; testing its device on four patients in Australia, it reported success in subjects being able to send text messages from their brains without physically typing anything [4].

[1] https://twitter.com/neuralink/status/1661857379460468736?s=20
[2] https://www.reuters.com/investigates/special-report/neuralink-musk-fda/
[3] https://www.youtube.com/watch?v=NhAU8p985-4
[4] https://bit.ly/3II4FCK

Photograph: vecstock/Freepik