Controlling a machine with your mind used to be science fiction. Now it is a regulated medical product, at least in China.

Earlier this year, China’s National Medical Products Administration approved NEO, a coin-sized brain-computer interface developed by Shanghai-based NeuraMatrix and Tsinghua University researchers, for commercial use in patients with spinal cord injuries. It is the first time any national regulator has granted commercial approval to an invasive BCI device.

How NEO works

During a 90-minute procedure, the device’s eight sensors are placed on the dura mater, the protective membrane covering the brain. Unlike Neuralink’s approach, which inserts electrode threads directly into brain tissue, NEO sits on top of the membrane.

The system decodes brain signals in real time, enabling patients to control a pneumatic glove with their thoughts. Actions like grasping objects or drinking water become possible for people who had lost the ability to move their hands.

China’s industrial playbook

The approval follows the same state-backed strategy that propelled China’s electric vehicle industry to global dominance. Beijing designated BCI as one of six strategic future industries, set a national goal of world leadership in brain technology by 2030, and removed regulatory barriers to accelerate clinical trials.

The result is a wave of Chinese BCI startups backed by state funding and fast-tracked through a regulatory process that took years in other countries. The approach prioritises speed and scale over the more cautious, staged approval pathways that the US Food and Drug Administration requires.

Where the US competitors stand

Neuralink has implanted its N1 device in at least 21 patients under research protocols. Its first patient, Noland Arbaugh, demonstrated the ability to play chess, browse the web, and control a cursor with thought alone.

But Neuralink does not yet have commercial approval. The company plans to ramp up to high-volume production and near-fully automated surgery in 2026, but FDA clearance for commercial sale is realistically years away.

Synchron, which inserts its Stentrode device through the jugular vein rather than through open brain surgery, holds the first FDA investigational device exemption for a permanently implanted BCI and is using a $200 million Series D to fund a pivotal trial this year. Precision Neuroscience took a different route, clearing the 510(k) pathway in April 2025 and partnering with Medtronic to embed its technology into existing neurosurgery systems.

No BCI is commercially available in the United States. All current implants are performed under research protocols or expanded access programmes.

What BCI can already do

The technology has moved well beyond laboratory demonstrations. Patients with implanted BCIs have browsed the internet, moved robotic arms, and transcribed thoughts into text.

The advances are driven by two converging trends: better hardware that can read more brain signals with less surgical risk, and AI models that can decode those signals faster and more accurately. As both improve, the range of actions a BCI can translate expands.

The ethical frontier

At its best, BCI technology restores autonomy for millions of people who have lost it to paralysis, blindness, hearing loss, or other conditions. The medical case is clear and the need is enormous.

The harder questions begin when the technology moves beyond restoration. Some researchers believe BCIs could lead to new forms of AI by modelling how the brain processes information. Others see a path to augmented human abilities, enhancing memory, accelerating learning, or enabling direct brain-to-brain communication.

Those possibilities raise questions that regulators are not yet equipped to answer. Who owns the data a brain implant collects? Can a government compel access to neural signals? What happens when the line between treating a disability and enhancing a healthy brain becomes commercial rather than medical?

China’s approval of NEO is a milestone for patients who need the technology now. It is also the starting gun for a global competition in which the rules have not yet been written.