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Neuralink's human brain-computer interface trials

Neuralink's human brain-computer interface trials

New Capabilities
By Newzino Staff |

From First Implant to Global Expansion in Two Years

January 28th, 2026: Two-Year Milestone: 21 Participants

Overview

Two years ago, Neuralink implanted a coin-sized chip in Noland Arbaugh's brain—the first human to receive the company's Telepathy device. As of January 28, 2026, twenty-one people across four countries are using Neuralink implants to control computers, phones, and robotic arms with their thoughts. Several participants now exceed the cursor-control speed of able-bodied people using a mouse.

The expansion from one experimental patient to a multinational cohort of 21 marks the transition from proof-of-concept to scaled clinical testing. Neuralink has announced 2026 as its first year of high-volume production, with plans to automate implantation surgery and begin human trials for Blindsight, a device designed to restore vision to the fully blind.

Key Indicators

21
Total Participants
People with Neuralink implants across the United States, Canada, and the United Kingdom as of January 2026
40 WPM
Typing Speed
Words per minute achieved by participants typing through imagined finger movements
10+ BPS
Cursor Control
Bits per second achieved by some participants—exceeding the 8-10 BPS typical of able-bodied mouse users
0
Serious Device Events
Zero serious device-related adverse events reported across all trials

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People Involved

Noland Arbaugh
Noland Arbaugh
First Neuralink Participant (Active user, pursuing neuroscience degree)
Alex (pseudonym)
Alex (pseudonym)
Second Neuralink Participant (Active user)
Elon Musk
Elon Musk
Neuralink Co-founder and Primary Funder (Active company leadership)
Dr. Andres Lozano
Dr. Andres Lozano
Lead Surgeon, CAN-PRIME Study (Leading Canadian trials)

Organizations Involved

Neuralink
Neuralink
Neurotechnology Company
Status: Conducting multinational clinical trials

Brain-computer interface company developing implantable devices to restore function in people with paralysis and, eventually, augment human cognition.

U.S. Food and Drug Administration
U.S. Food and Drug Administration
Federal Regulatory Agency
Status: Overseeing Neuralink's U.S. trials

Federal agency responsible for protecting public health through regulation of medical devices, drugs, and other products.

Barrow Neurological Institute
Barrow Neurological Institute
Medical Research Institution
Status: Primary U.S. surgical site for Neuralink trials

Phoenix-based neurological treatment and research center where Neuralink's first human implant surgeries were performed.

Timeline

  1. Two-Year Milestone: 21 Participants

    Milestone

    Neuralink announces it has expanded to 21 participants across four countries, with several exceeding able-bodied cursor-control speeds. The company reports zero serious device-related adverse events.

  2. Musk Announces 2026 Production Plans

    Statement

    Elon Musk announces on X that Neuralink will begin high-volume production of brain-computer interface devices in 2026, with a nearly fully automated surgical procedure.

  3. First UK Patient Implanted

    Medical

    Paul, a patient with motor neuron disease, receives the first UK Neuralink implant at UCLH's National Hospital for Neurology and Neurosurgery. He controls a computer cursor hours after surgery.

  4. First Surgery Outside United States

    Medical

    Dr. Andres Lozano performs the first Neuralink implant surgery outside the United States at Toronto Western Hospital. The Canadian patient controls a computer cursor within hours.

  5. GB-PRIME Study Launches in UK

    Clinical

    Neuralink launches the GB-PRIME study at two sites in Great Britain: University College London Hospitals and Newcastle Hospitals. The study will enroll up to seven participants.

  6. $650 Million Series E Funding

    Financial

    Neuralink closes a $650 million Series E round led by investors including ARK Invest, Founders Fund, and Sequoia Capital, valuing the company at $9 billion—more than double its 2023 valuation.

  7. Health Canada Approves CAN-PRIME Trial

    Regulatory

    Health Canada approves Neuralink's first clinical trial outside the United States, to be conducted at University Health Network in Toronto.

  8. Blindsight Gets Breakthrough Designation

    Regulatory

    The FDA grants breakthrough device designation to Neuralink's Blindsight implant, designed to restore vision by stimulating the visual cortex directly, bypassing damaged eyes.

  9. Second Patient 'Alex' Implanted

    Medical

    Alex, a former automotive technician with spinal cord injury, receives the second Neuralink implant. Modified surgical protocols—reducing brain motion and the gap between implant and brain—prevent thread retraction.

  10. Software Fix Restores Functionality

    Technical

    Neuralink modifies its algorithms to be more sensitive to neural signals, restoring significant cursor-control capability despite the physical thread retraction.

  11. Thread Retraction Setback

    Technical

    Up to 85% of electrode threads in Arbaugh's brain retract from their original positions, significantly reducing the device's signal capture. Air trapped in the skull during surgery is identified as a possible cause.

  12. First Human Implant: Noland Arbaugh

    Medical

    Noland Arbaugh, 29, becomes the first person to receive Neuralink's Telepathy implant at Barrow Neurological Institute. The two-hour surgery places a coin-sized chip connected to over 1,000 electrodes in his motor cortex.

  13. FDA Approves Human Clinical Trials

    Regulatory

    After additional safety testing, the FDA approves Neuralink's PRIME Study for human trials in patients with quadriplegia due to spinal cord injury or amyotrophic lateral sclerosis (ALS).

  14. FDA Rejects Human Trial Application

    Regulatory

    The FDA rejects Neuralink's application for human trials, citing dozens of concerns including lithium battery safety, potential wire migration, and device removal procedures.

  15. FDA Breakthrough Device Designation

    Regulatory

    The FDA grants Neuralink breakthrough device designation, allowing limited human testing under expedited guidelines.

  16. Neuralink Founded

    Company

    Elon Musk and eight neuroscientists establish Neuralink in San Francisco to develop implantable brain-computer interfaces.

Scenarios

1

Neuralink Receives FDA Approval for Commercial Device

Discussed by: IEEE Spectrum, industry analysts, and Morgan Stanley's $400 billion BCI market projection

If clinical trials continue demonstrating safety and efficacy through 2026-2027, Neuralink could seek premarket approval for the Telepathy device, potentially becoming the first high-bandwidth, fully wireless BCI approved for commercial use in paralysis patients. The FDA's breakthrough device designation for both Telepathy and Blindsight suggests regulatory willingness to expedite review. Approval would trigger rapid scaling given the reported 10,000-person waitlist.

2

Blindsight Restores Vision in First Human Patient

Discussed by: Neuralink updates, Musk statements, and ophthalmology publications

Neuralink has announced plans for its first Blindsight human implant in 2026, pending regulatory approval. Initial results will likely show low-resolution vision—Musk compared early capability to 'Atari graphics.' Success would represent a major breakthrough for the estimated 40 million blind people worldwide, though achieving functional vision useful for navigation remains uncertain.

3

Competitors Outpace Neuralink in Specific Applications

Discussed by: MIT Technology Review, STAT News, and Paradromics announcements

Synchron's less-invasive stentrode approach (inserted via blood vessels without open brain surgery) may prove more attractive to risk-averse patients and regulators. Paradromics received FDA approval for speech restoration trials in late 2025. Blackrock Neurotech's Utah Array has over 20 years of human implantation data. These competitors could win FDA approval for specific applications before Neuralink, fragmenting the market by use case.

4

Long-Term Safety Concerns Slow Expansion

Discussed by: Reuters investigations, medical ethicists, IEEE Pulse

The thread retraction in the first patient highlighted that long-term device stability remains uncertain. If participants experience significant complications at 3-5 years post-implant—such as additional thread retraction, infection, or cognitive effects—regulators could pause trials or require extensive redesign. The brain's response to permanent foreign objects over decades remains largely unknown.

Historical Context

BrainGate and Matt Nagle (2004)

June 2004

What Happened

Matt Nagle, 25, became the first paralyzed person to control a computer cursor using an implanted brain-computer interface. After a stabbing left him quadriplegic, researchers at Brown University implanted a 96-electrode Utah Array in his motor cortex. Nagle could open emails, control a TV, and move a robotic hand—revolutionary capabilities that took years of academic research to achieve.

Outcome

Short Term

Nagle demonstrated proof-of-concept for thought-controlled devices. The research team published landmark papers validating BCI technology for human use.

Long Term

BrainGate trials continued for over a decade, implanting dozens of patients and establishing the safety record that informed FDA guidance for all subsequent BCI devices, including Neuralink.

Why It's Relevant Today

Neuralink's achievement of 21 participants in two years, with some controlling devices within hours of surgery, shows how far the technology has advanced from the months of training required in early BrainGate trials.

Cochlear Implant Commercialization (1984-1990s)

1984-1995

What Happened

The FDA approved the first cochlear implant for adults in 1984, then for children in 1990. These devices bypass damaged hearing structures to stimulate the auditory nerve directly—conceptually similar to what Neuralink's Blindsight aims to do for vision. Early cochlear implants faced skepticism about whether electronically-induced hearing could be functionally useful.

Outcome

Short Term

Initial recipients reported basic sound awareness rather than natural hearing. Critics in the deaf community opposed the technology as unnecessary medicalization.

Long Term

Over one million people now use cochlear implants worldwide. Modern devices enable phone conversations and music appreciation. The technology became standard of care for severe hearing loss.

Why It's Relevant Today

Cochlear implants demonstrate how neural interface technology can progress from crude initial functionality to transformative capability over decades—a trajectory Neuralink hopes to replicate for motor control and vision.

Theranos Collapse (2015-2018)

2015-2018

What Happened

Blood-testing startup Theranos, valued at $9 billion and led by a charismatic founder with bold promises, collapsed when investigations revealed its technology didn't work as claimed. The company had conducted limited testing on actual patients while publicly announcing revolutionary capabilities.

Outcome

Short Term

Theranos dissolved. Founder Elizabeth Holmes was convicted of fraud in 2022.

Long Term

The scandal increased scrutiny of heavily-hyped health technology startups and reinforced the importance of transparent clinical data over founder promises.

Why It's Relevant Today

Neuralink shares surface similarities with Theranos—a $9 billion valuation, a famous founder making ambitious claims—but has publicly demonstrated its technology in identified patients and published clinical data, distinguishing it from Theranos's secretive approach.

12 Sources: