Musk’s Neuralink Animal Lab Cited For ‘Objectionable Conditions’

Elon Musk’s Neuralink has been cited for animal-welfare violations by a US federal regulator, documents have revealed.

Reuters reported that a letter to the US Congress dated 29 November, revealed that an animal testing laboratory at Neuralink was found to have “objectionable conditions or practices” by the Food and Drug Administration (FDA).

It comes after it was reported in December 2022 that Neuralink was under federal investigation for potential animal-welfare violations, amid internal staff complaints that animal testing at Neuralink was being rushed, causing needless suffering and deaths.

FDA cites lab

That federal probe was opened by the US Department of Agriculture’s Inspector General at the request of a federal prosecutor, and focused on violations of the Animal Welfare Act, which governs how researchers treat and test some animals.

It should be noted that Neuralink had previously denied those animal abuse allegations.

But now the FDA has cited an animal testing laboratory at Neuralink for “objectionable conditions or practices”, and has urged the firm to address the problems, Reuters reported.

FDA inspectors apparently identified the issues at Neuralink’s animal testing facilities in California in June 2023, several weeks after the agency had given the company the green light for a small study of its brain implant in humans, according to the letter to Congress.

The agency was responding to concerns raised by Earl Blumenauer, a House Democrat from Oregon who has focused on animal welfare.

Device safety

The FDA told Blumenauer the issues found at Neuralink warranted voluntary remediation measures by the company. But they were not considered severe enough to require regulatory action by the agency.

“While the company did receive citations related to documentation of its animal research, the FDA’s inspection did not find evidence of any violations that would undermine the device’s safety,” the FDA said in a statement in response to questions from Reuters.

It did not provide further details of the areas of concern.

Reuters reported in February 2024 that FDA inspectors had found problems with quality controls and record keeping at Neuralink’s lab in California during a June 2023 inspection, but had yet to determine what degree of action was warranted.

The FDA declined to say whether these were the same objectionable conditions cited in the letter, Reuters reported.

Neuralink did not respond to a request for comment about whether it had fixed any of the problems identified by the FDA.

Brain implant

Neuralink had been handed the official go-ahead in September 2023 to begin recruitment for a human subject, and in January 2024 it had implanted a test device in its first patient.

In February 2024 the firm revealed its first implant patient could control a computer mouse with his thoughts.

Then in March the patient was revealed to be Noland Arbaugh, aged 29, who is a quadriplegic after he was paralysed below the shoulders after a diving accident in 2016.

Neuralink livestreamed a video of Arbaugh using his mind to play online chess. The implant has also allowed Arbaugh to play video games, use the internet, as well as allowing him to move a computer cursor with his thoughts.

But in May Neuralink revealed that Arbaugh’s implant had in the weeks following its first in-human procedure developed a malfunction, but was still working. In response to this change, Neuralink modified the recording algorithm to be more sensitive to neural population signals to enable the device to keep working.

Neuralink has since implanted a device in a second US patient.

Neuralink rival

Neuralink is competing with Synchron (backed by Bill Gates and Jeff Bezos), which had received US regulatory clearance for human trials back in 2021 and had already completed studies in four people in Australia.

In September 2023 it was revealed that Synchron brain-computer interface had been implanted in first six US patients.

In August 2024 the first use of the Apple Vision Pro headset with its brain computer interface was demonstrated by US patient called Mark with ALS.

It came after the firm had a month prior incorporated OpenAI’s AI system with its brain-computer interface (BCI) technology in the same patient, to enable patients with severe paralysis who have lost upper limb mobility to interact with the digital world hands-free, through thought alone.

Unlike Elon Musk’s Neuralink which directly implants a device onto a person’s brain (requiring open brain surgery), the Synchron BCI is a stent-like device that is instead implanted in the blood vessel on the surface of the motor cortex of the brain via the jugular vein, through a minimally-invasive endovascular procedure.

Regulation reduction?

Elon Musk has been tasked by President-elect Donald Trump with slashing government spending at federal agencies such as the FDA.

However Musk and Doge are also looking to slash government regulation, and Elon Musk has repeatedly clashed with US federal agencies over the years.

This has led to concerns about possible conflicts of interest, that Musk and Doge could seek to reduce regulations surrounding his firms.