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Elon Musk says neuralink should be ready for human testing in six months

BY DANIELA HERNANDEZ | UPDATED DEC 01, 2022 12:48 AM EST

Neuroscience startup also showcases ‘telepathic typing’ in monkey with brain implant, other capabilities in live-streamed update

Elon Musk‘s startup Neuralink Corp. should be ready to test its technology on humans in six months, the entrepreneur said Wednesday during a live-streamed update about progress the company has made with its brain-implant technology.

Neuralink has submitted most of its paperwork to the U.S. Food and Drug Administration, which oversees medical devices, including neural implants, Mr. Musk said. In 2019, he said the company planned to seek the FDA’s approval for human testing and predicted it could begin as soon as 2020.

“We are now confident that the Neuralink device is ready for humans, so timing is a function of working through the FDA approval process," Mr. Musk said in a tweet during the event.

During a question-and-answer session, the company said it was working to address concerns from the FDA regarding overheating of the device and also toxic chemicals seeping into the brain from the implant, both of which could cause damage.

Mr. Musk said the implants are compact and that he would feel comfortable getting one now. He teased the possibility that he will eventually have an implant for a future demonstration.

“I could have a Neuralink device implanted right now and you wouldn’t even know, hypothetically," he said.

The company wants to be able to help restore vision and enable people with severe disabilities to move and communicate by decoding brain activity. Eventually, Neuralink wants to open clinics where patients could get a device implanted into their brains by their surgical robots, which the company also showcased at the Wednesday event. The robot surgeon threads Neuralink’s tiny proprietary electrodes, or brain-signal recording wires, into the brain.

Mr. Musk showed a video of “telepathic typing" from a monkey that has a Neuralink brain implant. The animal wasn’t typing into a keyboard but was able to move a cursor to images of letters.

“He’s moving the cursor with his mind," he said. “He can’t actually spell. I don’t want to oversell this thing."

Neuralink has been testing its implant technology on nonhuman primates for several years, including in April 2021, when the company released a video showing that a monkey implanted with two Neuralink devices could play a videogame called Pong as the device translated its brain activity into commands with the help of machine-learning software.

Clinical testing that proves an implantable device is safe and effective long-term would be necessary before a brain-computer interface, like Neuralink’s, could be widely rolled out to patients, neurotechnology experts said.

“That’s a big challenge," said Sumner Norman, chief neuroscientist at AE Studio, a development agency with a dedicated team of brain-computer interface engineers.

In the past year, Neuralink has been challenged with safety concerns after several of its monkeys had to be euthanized, including for suspected device-associated infections. It is standard practice in pharmaceutical and medical-device development to do preclinical testing on animals.

“We’re not cavalier about putting devices into animals," Mr. Musk said Wednesday.

Other researchers have managed to use a brain-computer interface to enable monkeys to produce words on a computer screen.

Last year, University of California, San Francisco, researchers used an experimental brain implant to translate a patient’s brain signals into words on a screen. Synchron Inc., a neurotech company developing a brain implant that is threaded into the brain’s blood vessels instead of interacting with brain tissue itself, has allowed five patients to type, according to Tom Oxley, the company’s chief executive.

Advancements in artificial intelligence, the miniaturization of electronics and new surgical techniques have sparked a flurry of investment and development into brain-computer interfaces, according to Michael Mager, chief executive of Precision Neuroscience Corp., which is working on a film-like sensor that sits on top of the brain and is inserted through a tiny slit in the skull.

Several companies are going after restoring sight, including Neuralink.

Science Corp.—founded by Max Hodak, formerly president of Neuralink—aims to use a combination of gene therapy, a thin retinal implant and smart glasses to help restore vision. Blackrock Neurotech recently announced it was developing an ultrathin, flexible implant called Neuralace for that same purpose, according to Florian Solzbacher, the company’s co-founder and president.

The technology would take electrodes, often called channels, and deliver into the visual system thousands of pulses of electricity to create the perception of seeing objects, Dr. Solzbacher said.

“For that, you need thousands of channels, and the more the better," Dr. Solzbacher said.

So far, researchers have been able to re-create the perception of edges and other simple shapes—basically the equivalent of an electronic walking stick, Dr. Solzbacher added—but nothing that approximates what we would interpret as full vision. He said he hoped the device would be available to researchers in 2024.

“The challenge is building something that is both high-channel count and can last for a long time in the body," said Matt Angle, chief executive of neurotech firm Paradromics Inc.

Most neural implants to date have been one-way highways of information, taking signals the brain generates and translating them into commands that an external device like a computer can then use to “type" or play videogames.

But developers hope the next generation of devices will be able to shuttle information into and out of the brain, for instance, to restore our senses and help with movement. Mr. Musk made several references to this “read and write" capability Wednesday.

Precision Neuroscience is working on a device that can both record from the brain and send signals into it. In January, the company said its implant could record from and stimulate areas of the brain involved in vision and the perception of touch.

During the presentation, Neuralink said it had implanted its device into the visual cortex of two monkeys already and used it to record brain activity and to create the perception of seeing tiny spots of light.

The ability of neural implants to “create the perception of touch or vision—that would be a huge win," said Dr. Norman of AE Studio.

These next-generation devices augment some of the ethical concerns about brain implants. Some have called them the last frontier of human privacy.

“People identify their sense of self most closely with their brains," said Nita Farahany, a Duke University neuroethicist. “Writing to the brain has the great peril to manipulate and override our choices and preferences."

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