Enlarge / An on-stage demo of the surgical robot. That could be you. (credit: Neuralink )

Billionaire Elon Musk posted on social media late Monday that his brain-computer interface company, Neuralink, implanted an experimental device into the brain of a human for the first time Sunday.

According to Musk's posts , which appeared on the platform formerly known as Twitter, the recipient is "recovering well," and the results in the first 24 hours show "promising neuron spike detection." Neuralink implanted the person with a device called Telepathy, which is intended to allow users to control devices, such as phones and computers, only by thinking.

The implantation comes around eight months after the company announced that the Food and Drug Administration had finally granted a long-sought approval to begin its first human trial. Recruitment for the trial began in September. Musk had claimed to be nearing trials starting as early as 2020, but the FDA reportedly denied approval in 2022 , citing a list of dozens of "deficiencies" and safety concerns that Neuralink had yet to address.

Enlarge / An on-stage demo of the surgical robot. That could be you. (credit: Neuralink )

After years of delays , regulatory rejections, and allegations of animal abuse , Elon Musk's brain-computer interface company, Neuralink, is now recruiting its first human volunteers to have an experimental robot implant an experimental device directly into their brains.

In a blog post Tuesday , the company announced that an independent institutional review board and an unnamed hospital site granted approval for the trial to start recruiting volunteers.

Neuralink says it aims to enroll people with quadriplegia due to a spinal cord injury or ALS (amyotrophic lateral sclerosis). Volunteers will have a wireless brain-computer interface implant, dubbed N1, surgically embedded into their brains by the company's experimental surgical robot, R1. The implant device is said to have 1,024 electrodes distributed across 64 threads thinner than a human hair. After R1 inserts the threads into the appropriate brain region, the electrodes are designed to record neural activity related to movement intention, and an experimental app from the company will decode the signals. The goal of the N1 implantation is to allow trial participants to control a computer cursor or keyboard using only their thoughts. This trial will primarily evaluate safety, but also get a glimpse of efficacy, Neuralink says.

Enlarge (credit: Getty | Jakub Porzycki )

The Food and Drug Administration denied a human-trials application from Elon Musk's brain-computer interface company, Neuralink, in early 2022, citing dozens of concerns about the company's device that employees are still working to address, according to a report by Reuters . The report is based on interviews with seven current and former Neuralink employees.

The revelation of the FDA rejection tracks with the thin public progress reports from the company, which place Neuralink behind rivals as well as Musk's ambitious timelines. Musk, who co-founded Neuralink in 2016, said in 2019 that the company aimed to start human trials by the end of 2020 and held lofty goals of curing spinal cord injuries and dementia. In a November 2022 presentation, which showed little technological progress , Musk said the company was still about six months away from human trials.

According to a company document from last fall, Neuralink expected to get FDA authorization for trials by March 7—next week. But employees who spoke with Reuters said they are not confident they'll get it, with one calling it a "gamble."

Enlarge / Pager, a 9-year-old Macaque, plays MindPong with his Neuralink. (credit: YouTube/NeuraLink )

The Department of Transportation is investigating allegations that Elon Musk's brain-computer interface company, Neuralink, violated federal transportation regulations when it shipped contaminated implants removed from the brains of deceased research monkeys infected with multiple types of dangerous pathogens. The alleged violations could have put humans at risk of exposure to hazardous germs, including drug-resistant bacteria and a potentially life-threatening herpes virus.

Reuters was the first to report the department's investigation , which was sparked by allegations brought Thursday by the Physicians Committee for Responsible Medicine (PCRM), a medical group that advocates for animal welfare in medical research. The Department of Transportation confirmed to Ars on Friday that it has opened a standard investigation of Neuralink in response to PCRM's allegations.

In a letter addressed to Transportation Secretary Pete Buttigieg and William Schoonover, associate administrator of the department's Pipeline and Hazardous Material Safety Administration, the PCRM laid out its evidence for possible violations of hazardous material transportation regulations based on a trove of documents and emails obtained through public record requests. The advocacy group says the evidence shows Neuralink's contaminated hardware was not properly packaged to prevent exposure to humans and that Neuralink employees who transported the material had failed to undergo legally required training on how to safely transport such material.

Enlarge / The on-stage demo of the surgical robot practically extended into the audience. (credit: Neuralink )

On Wednesday night, Elon Musk hosted an update from his brain-computer interface company, Neuralink. Most of the update involved various researchers at the company providing overviews of the specific areas of technology development they were working on. But there wasn't anything dramatically new in the tech compared to last year's update , and it was difficult to piece the presentations together into a coherent picture of what the company plans to do with its hardware.

But probably the most striking thing is that last year's update indicated that Neuralink was getting close to human testing. Over a year later, those tests remain about six months out, according to Musk.

Lots of tech

Neuralink involves a large series of overlapping technical efforts. The interface itself requires electrodes implanted into the brain. To connect those electrodes with the outside world, Neuralink is using a small bit of hardware implanted in the skull. This contains a battery that can be recharged wirelessly, and a low-power chip that gathers data from the electrodes, performs some simple processing on it, and then transmits that data wirelessly.