If someone told you they could put a chip in your brain so you could control a computer with your thoughts, your reaction would probably be split somewhere between “that’s incredible” and “absolutely not.” That tension — between awe and anxiety — is essentially the entire brain-computer interface industry in 2026. And Neuralink, the company most people associate with this technology, might simultaneously be its greatest champion and its biggest problem.
The clinical work is genuinely remarkable. But then the hype machine kicks in, and the rest of the industry collectively loses its mind.
The Revolving Door
In December 2025, Neuralink hired David McMullen. If that name doesn’t ring a bell, here’s why it matters: McMullen was the director of the FDA’s Office of Neurological and Physical Medicine Devices — literally the office responsible for reviewing and regulating brain-computer interfaces, including Neuralink’s own products.
Reuters broke the story, and competitors were furious. McMullen had longtime ties to Neuralink executives — they had overlapped at a neuroscience lab at Duke University. His new title at Neuralink? Head of Medical Affairs.
The optics get worse in context. Earlier in 2025, Musk’s Department of Government Efficiency (DOGE) led federal workforce cuts that hit the FDA hard. Approximately twenty employees were fired from the very division that reviews devices like Neuralink’s. The FDA had to ask some of those scientists to come back.
So the agency reviewing Neuralink lost staff partly because of Musk’s cost-cutting initiative, and then Neuralink hired the boss of that very office. McMullen released a statement saying the role “combines scientific rigor, direct patient impact, and the chance to move the entire field of BCI forward.” Noble-sounding, but STAT News ran a deep investigation in January 2026 with interviews from competitors, investors, and former regulators, and the core worry was clear: Neuralink is perceived as the industry leader, and its actions set the tone for how regulators and insurers view all BCIs.
If regulators start side-eyeing the whole field, every company developing brain implants suffers — not just Neuralink.
The Patients in the Middle
The people who matter most in this story are the ones with implants in their heads. Noland Arbaugh, Neuralink’s first patient, is a twenty-nine-year-old who was paralyzed from the shoulders down in a diving accident. He received his implant — called The Link, about the size of a quarter — in January 2024.
Within weeks, Arbaugh was controlling a computer cursor with his thoughts. Playing chess. Browsing the internet. He told The Debrief: “I was not expecting it to be as good as it is. There were moments when I realized, this is a much bigger deal than I thought.”
For someone who cannot move their limbs, being able to interact with a screen using pure thought is transformative. But there were problems. About a month after surgery, 85% of the tiny electrode threads retracted from his brain tissue. Reuters reported that Neuralink had actually known about this thread retraction issue for years.
Neuralink’s engineers managed to work around it through software modifications — adjusting the recording algorithms to compensate. Arbaugh himself has been remarkably positive, joking that “maybe it is doing something terribly wrong to my brain” while adding he hasn’t felt any adverse effects. The second patient — identified only as Alex — received the implant later in 2024 with no reported thread retraction issues.
By September 2025, Neuralink announced that twelve people worldwide had received implants. In April 2025, they implanted a paralyzed veteran named RJ at the Miami Project to Cure Paralysis.
Here’s a statistic that puts the entire field in perspective: a researcher named Michelle Patrick-Krueger at MIT Technology Review documented every person who has ever controlled a computer directly with implanted brain electrodes, going all the way back to 1998. The total across twenty-six years? Seventy-one people. You are statistically more likely to be friends with a Mega Millions jackpot winner than to know someone with a BCI.
The Competitor Landscape
Neuralink isn’t alone, and its competitors take very different approaches.
Synchron, based in New York, avoids brain surgery entirely. Their device — called a stentrode — is essentially a stent with electrodes on it, inserted through a vein in the neck into a blood vessel in the brain. No craniotomy required. CEO Tom Oxley argues this makes the device far more scalable. Synchron has implanted ten patients — six in the U.S. and four in Australia — the most simultaneous volunteers of any BCI group.
The trade-off is resolution. Because the stentrode sits inside a blood vessel rather than directly in brain tissue, it captures fewer neural signals. Users get what Synchron calls a “switch” — basically an on-off control signal sufficient for toggling through menus or selecting prewritten messages, but not fine cursor control or gaming. Simpler, but less powerful.
Blackrock Neurotech has been in this space longer than anyone. Their Utah Array — a small bed-of-nails-looking electrode grid — has been implanted in over forty patients since 2004 through research studies like BrainGate. The numbers are staggering: more than 30,000 total days of in-brain recording across all patients, with zero FDA-reported serious adverse events.
Why don’t we hear about Blackrock more? Because they don’t have Elon Musk. Co-founder Florian Solzbacher has spoken publicly about the challenges of scaling, emphasizing that going from dozens to thousands of devices requires rigorously validated processes. It’s careful, methodical language. The kind that doesn’t generate headlines.
Medicine vs. Transhumanism: The Identity Crisis
Here’s where the story gets genuinely thorny. Neuralink’s clinical program — the PRIME study, helping people with ALS and paralysis — is legitimate, important medical device development. Real patients, real outcomes, real improvement in quality of life.
But then Bloomberg reported in September 2025 that Neuralink is simultaneously developing two tracks: a speech trial to translate thoughts into text for speech-impaired people (still medical), and a nonmedical brain implant for healthy humans. The reporting mentions boosting memory, processing speed, even brain-to-brain communication. Musk has talked about “human-AI symbiosis” for years — the idea that humans need to merge with artificial intelligence to remain relevant as AI surpasses human capabilities.
This dual identity creates a serious practical problem. If you’re an insurance company deciding whether to cover a brain implant for an ALS patient, and the manufacturer is simultaneously talking about selling brain chips to gamers and tech enthusiasts, you start wondering: is this a medical device or a consumer gadget?
Regulatory frameworks matter here. Medical devices go through the FDA’s rigorous approval process. Consumer electronics don’t get the same scrutiny. The STAT News investigation found that competitors worry Neuralink’s transhumanist rhetoric could scare regulators into creating more restrictive frameworks for everyone, or make insurers reluctant to reimburse — which would directly hurt the patients who actually need this technology.
Carolina Aguilar, CEO of INBRAIN Neuroelectronics, told The Debrief: “Scaling responsibly in neurotechnology is not just a manufacturing factor. It’s a clinical, surgical, and systems consideration.” That’s pointed language aimed directly at Musk’s production promises.
On New Year’s Eve 2025, Musk posted on X that Neuralink would begin “high-volume production” of brain-computer interface devices in 2026 and move to an almost entirely automated surgical procedure. Most industry observers interpret “high-volume” as realistically hundreds moving toward low thousands per year — still an enormous leap from twelve.
The Abandonment Problem
A paper published in Frontiers in Human Dynamics in early 2025 raised another uncomfortable question: what happens to patients if the company ceases operations, or if costs become prohibitive?
When a BCI becomes essential to someone’s daily functioning — their primary interface with the digital world, their means of communication — its maintenance becomes critical. There is currently no regulatory framework for ensuring long-term device support. It’s analogous to having a pacemaker made by a startup: the technology is life-changing, but the business model matters profoundly.
This isn’t hypothetical. The history of medical technology is littered with companies that developed groundbreaking devices, then went bankrupt or were acquired, leaving patients with implanted hardware and no support infrastructure.
Where This Leaves Us
There’s no clean takeaway from the BCI story in 2026. The technology is genuinely miraculous for the people who have it. Noland Arbaugh’s life was materially changed. The twelve Neuralink patients, the ten Synchron patients, and decades of Blackrock research all represent real human progress.
But the hype machine around it could actually slow things down for everyone. The company bringing the most attention and funding to BCI technology might also be the one that makes regulators and insurers most hesitant. David McMullen leaving the FDA for Neuralink isn’t just a personnel move — it’s a symbol of how tangled the relationships between this industry and its regulators have become, especially against the backdrop of DOGE and the FDA staff cuts.
Brain-computer interfaces will almost certainly become standard medical devices within our lifetimes. The question is whether that happens through careful, patient-centered development — or through a hype cycle that treats paralyzed people as a stepping stone to consumer brain chips.
The patients are the ones who pay the price either way. That’s the story nobody wants to tell. But it’s the one that matters most.