US FDA approves human testing for Elon Musk’s Neuralink brain-implant system, after years of animal testing
Neuralink, the Elon Musk-founded start-up aimed at developing wireless brain-machine interfaces, has been approved for human testing.
The Food and Drug Administration (FDA) in the US has finally given the greenlight for human testing, after initially rejecting Neuralink’s application.
Last December Elon Musk, speaking to a crowd of select invitees in a presentation at Neuralink headquarters, had said Neuralink would begin human testing within the next six months.
Human testing
In March this year it was reported that Neuralink had approached a major US neurosurgery centre as a potential partner in human clinical trials, should they be approved by regulators.
The firm reported;y had been in talks with Barrow Neurological Institute, a Phoenix, Arizona neurological treatment and research organisation, for the potential trials.
Neuralink has been developing brain implants since 2016 and Musk has said he believes they will one day be as common as laser eye surgery.
Indeed, Musk has been previously stated called the brain implant a “Fitbit for your skull” and said it would stream music directly into a person’s brain, bypassing the need for earphones (and even ears) altogether.
The technology is intended to treat conditions such as paralysis and blindness by creating a direct digital connection with the brain, known as a brain computer interface (BCI).
But Musk also envisions both disabled and healthy individuals swiftly getting surgical implants to cure a number of conditions – ranging from obesity, autism, depression and schizophrenia, to enabling web browsing and telepathy.
Last year the US FDA had reportedly rejected Neuralink’s application to progress to human trials, citing major safety concerns.
Since then Neuralink has been working since then to gain approval, and the FDA has now issued its approval for Neuralink to launch its first in-human clinical study.
“We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!,” tweeted Neuralink. “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.
It said recruitment is not yet open for it clinical trial but will announce more information soon.
Animal testing
Neuralink has been testing its brain interface chip with animals for a number of years now.
In April 2021, Neuralink posted a video that showed a monkey playing a game of Pong using only signals from its mind.
That video showed the monkey first controlling the game using a joystick, and being rewarded with a banana smoothie delivered through a metal straw. Meanwhile the implanted chip records the brain signals used to control the joystick.
When the scientific team disconnected the joystick, the monkey continued to play, but now the game of “MindPong”, as the company nicknamed it, was apparently controlled using its brain signals only.
Neuralink had also previously showed a video of a pig called Gertrude (Gertie) with an implant that allowed her neural activity to be tracked as she looked for food.
In February 2022 Neuralink admitted eight monkeys had died during its research, as it responded to a legal complaint from anti animal testing group.
It has been reported that the company has killed about 1,500 animals, including more than 280 sheep, pigs and monkeys, following experiments since 2018.
Rushed testing?
Neuralink is facing federal probes over these deaths, amid concern of rushed testing.
Now it seems that Neuralink has addressed previous FDA concerns about the lithium battery of the device; the chance the implant’s wires could migrate within the brain; and the challenge of safely extracting the device without damaging brain tissue.
Neuralink it should be noted is lagging behind that of medical device rival Synchron, which crossed a major milestone in July 2021 by implanting its device in a patient in the United States for the first time.
Synchron had received US regulatory clearance for human trials back in 2021 and has already completed studies in four people in Australia. The company’s device has allowed paralysed people to text and type by thinking alone.