Is Neuralink Safe? Top Risks and Safety Insights Revealed

• Neuralink reported zero serious device-related adverse events as of January 2026, when it had 21 participants.
• The main risks are those of brain surgery, threads pulling back out of the brain, tissue reaction, and long-term device performance.
• The FDA cleared human trials in May 2023, and implants have since been performed in the United States, Canada, and the United Kingdom.

Neuralink's brain implant is an investigational device, and everyone who has one received it in a clinical trial. This article covers the evidence so far, the main risks, and how Neuralink addresses them.

Neuralink's safety record in human trials

Neuralink performed its first human implant in January 2024, and the patient, Noland Arbaugh, went on to play chess and browse the internet with his mind. On January 28, 2026, Neuralink reported 21 participants and "zero serious device-related adverse events" in its two-year update. Neura Pod's patient table lists 27+ publicly known patients as of October 2026.

The UK's first participant, Paul, received his implant in October 2025 at University College London Hospitals. Hours after surgery, Paul controlled a computer cursor, and he has since played games like Dawn of War. In Canada, the first two surgeries took place at Toronto Western Hospital in late August and early September 2025. A site in Abu Dhabi has approval to recruit, and no implant there has been reported as of October 2026.

Neuralink submitted data from three patients at Barrow Neurological Institute to the New England Journal of Medicine for peer review, according to Barrow's CEO. No paper had been published as of October 2026.

The implant holds 1,024 electrodes on flexible polymer threads: 64 threads in early implants and 128 thinner threads in later ones. Flexible threads are meant to cause less tissue damage than rigid electrode arrays.

Main risks and how Neuralink addresses them

• Surgical complications. Risk: infection, bleeding, or swelling from the opening in the skull. Mitigation: the R1 robot inserts the threads with micron precision, and the fully implantable system has no external wires. Participants have typically gone home within a day or two of surgery.
• Thread retraction. Risk: threads can pull back out of the brain, as many of Noland's did in 2024. Mitigation: 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.
• Tissue reaction. Risk: inflammation or scarring that weakens the signals. Mitigation: biocompatible materials, and the first participant has used his implant for more than 9,000 hours, according to Neuralink.
• Cybersecurity. Risk: someone intercepting or tampering with neural data. Mitigation: neural data is sent wirelessly over Bluetooth to the paired computer or phone during use, and Neuralink has not published its encryption details.
• Long-term performance. Risk: the device losing signal or failing over years. Mitigation: the PRIME study follows each participant for about 6 years, including 5 years of long-term follow-up, according to the PRIME brochure.

The FDA rejected Neuralink's first request to start human trials in 2022, citing concerns that included the lithium battery and the wires. Neuralink answered those questions before the FDA cleared the trials in May 2023.

FDA oversight

The FDA granted Neuralink an Investigational Device Exemption in May 2023. The company has since received Breakthrough Device Designations for Blindsight in September 2024 and for speech restoration in May 2025, which speed up the FDA's review without approving the device. Trials in Canada and the UK are also overseen by those countries' regulators.

Some experts have proposed no-fault compensation for people harmed by high-risk implants. Elon Musk has said: "We conduct thorough studies to confirm safety prior to trials."

Patient outcomes

After software changes, Arbaugh's cursor control reached about 8 to 9 bits per second, and Neuralink participants have since set a record of 11.32 bits per second, according to Neuralink's October 2026 update. The VOICE speech trial implanted its first participants in early 2026, and a third VOICE participant spoke with a voice decoded from his brain in September 2026.

This article was first published in October 2025 and corrected in October 2026; the latest patient count is on the patient table.