Elon Musk has announced that his brain-computer interface (BCI) company, Neuralink, now has 21 patients enrolled worldwide.
The BCI company began human implant trials two years ago, initially with Noland Arbaugh, the first human to receive “The Link,” and later expanded to 12 people using BCI chips to control computers and robotic limbs with their minds alone.
“A primary aim of our expanding clinical trials is to better understand these variations and improve both our hardware and the overall procedure for every participant,” Neuralink said in a statement.
The Link was designed to help people with spinal cord injury, amyotrophic lateral sclerosis (ALS), and other neurological conditions regain a sense of independence, while allowing them to contribute to society in a way that feels meaningful to them through direct communication between the brain and external devices. The device works by registering neural signals, which are then translated into digital commands.
The Link implant allows its users to control computers, smartphones, and assistive technologies solely with their thoughts. Currently, the implantable device is about the size of a quarter (23 mm in diameter and around 8 mm thick).
High Volume
On December 31, 2025, Elon Musk announced the company’s plans to begin “high-volume production of brain-computer interface devices,” according to a posting on X. The company said it plans to move toward “a streamlined, almost entirely automated surgical procedure in 2026. Device threads will go through the dura without the need to remove it.”
“This is a big deal,” Musk’s posting on X read.
However, what does high volume really mean? On January 12, Carolina Aguilar, CEO and co-founder of INBRAIN Neuroelectronics, one of Neuralink’s competitors, told The Debrief, “At this stage, we interpret ‘high-volume’ realistically as hundreds moving toward low thousands of implants per year.” She also notes that it could eventually reach “tens of thousands”.
Florian Solzbacher, co-founder and Member of the Board of Directors of Blackrock Neurotech, said the challenges presented with scaling “usually come in all areas.”
“It starts with capability, the processes, and the capacity to actually make that many devices,” Solzbacher said in an email to The Debrief, adding that that number—should it reach “tens of thousands, or hundreds of thousands of devices” would require “well-qualified, validated processes.”
Currently, the FDA oversees all BCIs in the United States, but last September, lawmakers chimed in and became aware of the rapidly developing technology that could one day become part of our consumer lifestyle. Senate Majority Leader Chuck Schumer, with Senators John Cornyn and Ron Wyden, proposed legislation to regulate BCIs last September, requesting that the FTC closely examine the policy for long-term use under the MIND Act.
“If something more serious happens, the FDA and other regulatory bodies can put their foot down and put you on hold,” Solzbacher told The Debrief in January. “A number of years ago, there were some issues with pacemaker leads, and the FDA just stopped the ability for a big device player to even sell any pacemakers.”
“Broad participation helps ensure that innovation is balanced with transparency, oversight, and public trust as these technologies move closer to real-world impact,” Aguilar added.
There is no doubt among lawmakers and BCI companies that there is a growing desire for the production of brain-computer interface chips. Still, questions arise over how data related to such technologies will be controlled, as well as privacy considerations, and ultimately, how this technology could change the state of our society.
Chrissy Newton is a PR professional and the founder of VOCAB Communications. She currently appears on The Discovery Channel and Max and hosts the Rebelliously Curious podcast, which can be found on YouTube and on all audio podcast streaming platforms. Follow her on X: @ChrissyNewton, Instagram: @BeingChrissyNewton, and chrissynewton.com. To contact Chrissy with a story, please email chrissy @ thedebrief.org.