As brain-computer interfaces inch closer to mainstream use, questions over data control and long-term effects remain unresolved
Neuralink now has 21 patients enrolled worldwide, founder Elon Musk has announced, signalling steady progress in human trials as the company works toward high-volume production of brain-computer interface devices.
The company began implant trials two years ago with Noland Arbaugh, the first person to receive its device known as “The Link.” It later expanded to 12 participants using the chips to control computers and robotic limbs with their minds.
“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 implant is designed to help people with spinal cord injuries, amyotrophic lateral sclerosis (ALS), and other neurological conditions regain independence by enabling direct communication between the brain and external devices. Neural signals are registered and translated into digital commands, allowing users to operate computers, smartphones, and assistive technologies using only their thoughts. The device is roughly the size of a quarter.
Musk said on Dec. 31 that the company plans to begin “high-volume production of brain-computer interface devices,” adding that it aims for “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.
What qualifies as high volume remains open to interpretation. Carolina Aguilar, CEO and co-founder of INBRAIN Neuroelectronics, said, “At this stage, we interpret ‘high-volume’ realistically as hundreds moving toward low thousands of implants per year,” adding that output could eventually reach “tens of thousands.”
Scaling production presents challenges across manufacturing and validation, according to Florian Solzbacher, co-founder and board member at Blackrock Neurotech.
“It starts with capability, the processes, and the capacity to actually make that many devices,” Solzbacher said in an email, adding that production in the “tens of thousands, or hundreds of thousands of devices” would require “well-qualified, validated processes.”
Regulators are also paying closer attention to the fast-developing field. The U.S. Food and Drug Administration currently oversees brain-computer interfaces in the United States, while lawmakers have proposed additional scrutiny. Senate Majority Leader Chuck Schumer, alongside Senators John Cornyn and Ron Wyden, introduced legislation last September requesting that the Federal Trade Commission examine long-term policy 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 said 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.
Interest in brain-computer interface chips is rising among companies and policymakers, but questions remain around data control, privacy, and how the technology could reshape society as it moves closer to broader adoption.
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