The Question
In January 2024, Neuralink — the neurotechnology company founded by Elon Musk — implanted its N1 chip in the brain of Noland Arbaugh, a 29-year-old Arizona man paralysed from the shoulders down after a diving accident. Within weeks, Arbaugh was controlling a computer cursor with his thoughts alone — playing online chess, navigating web pages, streaming video games for hours. He described the experience as feeling like using "the Force." He could do it lying down in total darkness.
Media attention focused on Musk's vision of human-computer symbiosis. Less well covered: Arbaugh was not remotely the first human with a brain-computer interface. Blackrock Neurotech has implanted devices in more than 36 people. The BrainGate consortium — Brown University, Stanford, and Massachusetts General Hospital — has run human trials of implanted BCIs since 2004. Neuralink brought a smaller, more sophisticated device and a vastly larger marketing budget. The merger of human brains and computers has been underway quietly for twenty years. Now it is becoming visible.
What the Evidence Shows
BCIs record the electrical activity of neurons. The motor cortex generates distinctive patterns when a person intends to move a limb — patterns still present even in patients whose spinal cords have been severed. A BCI records those signals, decodes the intended movement using machine learning trained on the patient's own neural activity, and translates it into digital output: a cursor movement, a robotic arm command, synthesised speech.
BrainGate demonstrated as early as 2012 that a woman with ALS could use a BCI to control a robotic arm well enough to drink from a bottle of coffee. In 2021, a BrainGate patient composed emails at roughly 40 characters per minute. Synchron's Stentrode device is inserted not through open brain surgery but through a blood vessel — threaded up the jugular vein into the motor cortex region — and has completed trials in Australia and the United States. Precision Neuroscience, founded by former Neuralink employees, is developing an ultra-thin electrode array that sits on the brain's surface, reducing surgical risk.
"I was playing chess online at 2am and I just kept thinking — I'm a cyborg. I have a computer in my head and I'm moving pieces with my mind. My roommate was asleep. Nobody knew. It was the most normal-feeling extraordinary thing I've ever experienced."
— Noland Arbaugh, Neuralink first human trial participant, May 2024 livestreamNeuralink's N1 chip is distinguished mainly by miniaturisation and wireless capability. Earlier BrainGate devices required a pedestal protruding through the skull, cabled to external hardware. Neuralink's chip is entirely implanted, communicates wirelessly, and recharges inductively through the scalp. It contains 1,024 electrodes — far more than any previous implant. The engineering is genuinely impressive, even if the underlying neuroscience is evolutionary rather than revolutionary.
"The question is no longer whether brains and computers can be connected. The question is what we will do when anyone can buy that connection, not just people who need it medically."
Why This Is Happening
Computing power has reached the threshold where real-time neural decoding is possible. A single electrode records dozens of neurons firing hundreds of times per second; mapping that onto intended movement or speech requires substantial computation. The machine learning revolution of the past decade produced decoding accuracy that was unachievable in 2010, and the same GPU infrastructure that runs large language models enables neural decoders that improve the longer they run on a patient's own data.
The patient population is large enough to justify serious commercial investment. Approximately 5.4 million people live with paralysis in the United States alone; globally, hundreds of millions have conditions — ALS, locked-in syndrome, stroke, spinal cord injury — that BCIs could address. It is a large, underserved population with no good alternatives, which is why Neuralink has raised over $700 million, Synchron over $145 million, and Precision Neuroscience $93 million.
The military is funding the basic science. DARPA has been the primary funder of BCI basic research for decades, through programmes including NESD and Restoring Active Memory. Its interest is dual: restoring function to injured soldiers, and eventually cognitive augmentation — enhanced memory, faster decision-making, direct communication with drones. That funding has kept the academic pipeline producing neuroscientists and device concepts regardless of commercial investment cycles.
What Could Happen
FDA approval of the first commercial BCI for motor restoration follows the success of Neuralink's, Synchron's, and Blackrock's trials. Insurance coverage in the United States begins for specific indications. The device is implanted by neurosurgeons at major centres in the way cochlear implants are today — specialist surgery, but routine within its domain. Hundreds of thousands of patients eventually benefit. Enhancement applications remain off-label and controversial.
A company operating in a jurisdiction with lighter-touch medical device regulation markets a BCI to healthy individuals claiming to enhance working memory or attention. The device is minimally invasive — perhaps a Stentrode-style endovascular implant. It attracts early adopters among technology professionals willing to accept surgical risk for competitive advantage. The ethical and regulatory debate it triggers forces governments to develop BCI-specific regulatory frameworks they currently lack.
A wireless BCI is compromised by a demonstrated cyberattack — researchers show they can intercept neural data or, more alarmingly, send signals into the device. No harm occurs to the patient, but the proof of concept is enough to halt approvals, trigger emergency regulation, and set the commercial BCI market back five years. Security researchers have already published papers demonstrating vulnerabilities in existing wireless neurostimulation devices.
What Can We Do
The merger of brains and computers raises questions that medical device regulation was never designed to answer. We are, as a society, significantly behind the technology in our thinking about what rules should govern it — and the window for getting ahead of it is closing.
Develop BCI-specific regulatory frameworks before commercial products arrive. The FDA currently treats BCIs as standard medical devices. They are not. A device that reads neural signals and learns from them, is wireless and therefore hackable, and sits inside a skull for decades requires its own regulatory category — covering cybersecurity standards, data ownership, and the conditions under which a device can be remotely updated or discontinued.
Establish clear data ownership rights for neural data. The signals a BCI records are, literally, the thoughts of the person wearing it. Who owns that data? Can the manufacturer train its algorithms on it, sell it, or have it subpoenaed? No jurisdiction has clear answers. Neural data requires the strongest possible privacy protections — stronger than health data generally — because it is more intimate than any other personal information.
Fund independent long-term safety research. Most BCI safety data comes from the companies developing the devices, who have obvious incentives to present their products favourably. Long-term independent studies of what happens to brain tissue around implanted electrodes over decades — whether there is cumulative inflammation, signal degradation, or neurological side effects — are essential and currently underfunded.
Begin the public conversation about enhancement now, not after products exist. The transition from medical BCI to enhancement BCI will not be marked by a clear announcement. It will happen gradually, driven by off-label use and by companies testing the regulatory boundaries. Society's preferences about whether cognitive enhancement via brain implant should be permitted, regulated, or prohibited need to be worked out through democratic processes before the market makes the decision by default.
- Neuralink — First human trial results, Noland Arbaugh, 2024
- BrainGate Consortium — Clinical trial data, Brown University, 2004–2024
- Synchron — Stentrode human trials, Australia and US, 2021–2024
- Blackrock Neurotech — Patient implant records and device history, 2023
- DARPA NESD Programme — Neural Engineering System Design reports, 2017–2023
- Forecast The World Research Desk — 800+ data sources