Why Is Neuralink Facing Criticism? Reasons and Responses
- Neuralink faces criticism mainly over its past animal testing and early FDA safety reviews.
- Elon Musk has pointed to welfare improvements, and Neuralink reported zero serious device-related adverse events in its human trials as of January 2026.
- Neuralink has answered transparency concerns by listing its trials publicly and submitting data for peer review.
Animal testing controversies
Neuralink tested the N1 device in animals before human use. Reuters reported in 2022 that about 1,500 animals, including monkeys, pigs, and sheep, had died in Neuralink's testing since 2018. Critics pointed to monkeys that went through multiple skull surgeries before euthanasia, and a Physicians Committee for Responsible Medicine filing alleged unnecessary suffering.
An FDA inspection in June 2023 cited Neuralink's own California animal lab for record-keeping and quality-control lapses, as Reuters reported in early 2024. Whistleblowers said rushed timelines increased complications, and lawmakers questioned whether the company was ready for human trials.
Elon Musk said in 2023 that no monkey died as a result of a Neuralink implant and that early implants went into "terminal" monkeys; WIRED and lawmakers disputed that account. Neuralink published a 2022 blog post describing its welfare protocols, including veterinary oversight.
FDA scrutiny and safety
The FDA rejected Neuralink's first human trial application in 2022 over concerns that included thread migration in the brain and battery risks. Approval came in May 2023 after revisions.
Many of first patient Noland Arbaugh's threads retracted, but software changes restored his performance without surgery. Neuralink reported zero serious device-related adverse events across 21 participants as of January 2026. UK patient Paul controlled a computer hours after his implant.
Elon Musk has said the R1 robot's precision is beyond what human surgeons can do. Participants now exceed 10 bits per second, with a record of 11.32 bits per second set in 2026.
Transparency and ethics
Scientists criticized Neuralink for announcing results on X instead of in journals, and its first trial was not listed on ClinicalTrials.gov at the start. Ethical worries include privacy and the risk of unequal access to future enhancements.
In July 2025, reporters found Neuralink listed as a self-certified "small disadvantaged business" in a federal database; the SBA said it did not vet the self-certification, as Fortune reported. Others question the hype around telepathy and AI symbiosis.
Neuralink submitted a paper on its first three participants to the New England Journal of Medicine.
Neuralink's responses
Musk has answered critics on X, stressing medical need and progress. After changes made following Noland's surgery, Neuralink reported higher signal quality in 18 of the next 20 participants and says it is still improving thread retention. Jon Noble, a UK participant, wrote in December 2025 that more than 10,000 people were on the US waiting list.
Trials in Canada and the UK went through ethics reviews, and a UAE site is recruiting. In the CONVOY Study, Alex Conley controls robotic arms. In November 2025, Musk shared a report that Noland hopes to receive a second implant below his spinal injury.
What comes next
Neuralink's roadmap targets about 10,000 channels in 2027, and its Blindsight and speech programs both have FDA Breakthrough Device Designations. The UK's MHRA approved the GB-PRIME trial. Most of the criticism concerns work done before human trials, and the human safety record so far is Neuralink's main answer to it.
This article was first published in October 2025 and corrected in October 2026; the latest patient count is on the patient table.
