Our Take
China beat the US to commercial invasive BCI approval by choosing a less surgically risky design, but calling this a 'race' misses the point: China wants scale and societal impact; the US wants first-mover technical superiority.
Why it matters
This is the first invasive brain implant cleared for routine clinical use outside experimental trials anywhere in the world, and China's government has declared BCI a national strategic industry. Thousands of paralyzed patients in China now have access to a working rehabilitation device, and dozens more BCIs are in the pipeline for 2028 approval.
Do this week
Neurotechnology researchers and biomedical device teams: map competitive timelines for the next three Chinese BCI approvals (Beinao-1 and others targeting 2028) and assess whether US regulatory pathways are structurally slower or just differently gated.
NEO becomes the first invasive BCI to exit clinical trials
In November 2024, Dong Hui, a 39-year-old paralyzed from the neck down by a 2018 spinal cord injury, underwent surgery to implant NEO, a coin-sized brain device developed by Shanghai-based Neuracle Technology and Tsinghua University. The implant sits on his dura mater (the brain's protective outer membrane) and transmits neural signals to a computer that controls a soft robotic glove. After 11 months of rehabilitation, Dong regained enough finger control to write his name by hand.
In March 2025, NEO became the first invasive BCI product approved for clinical use outside of trials by China's National Medical Products Administration. It is now available to patients aged 18 to 60 with spinal cord injuries and residual arm function, and China has already assigned it a unique health insurance code, enabling partial cost reimbursement for eligible patients.
Neuracle conducted 36 clinical trials of NEO since October 2023, with 32 trials occurring in 2025 alone. One trial was published as a preprint in July. Neuralink's N1 implant, which penetrates the brain cortex directly, has not yet received approval outside the United States.
Design and regulatory pathway explain the speed
NEO's approval moved faster than comparable devices partly because of its lower surgical risk. The implant sits atop the dura mater rather than penetrating brain tissue, reducing the likelihood of hemorrhage, glial scarring, and long-term signal degradation, according to Avinash Singh, a BCI researcher at the University of Technology Sydney. Neuralink's N1 requires deeper cortical implantation and thus faces stricter regulatory oversight.
China also granted NEO an expedited regulatory pathway. The US Food and Drug Administration's approval process typically takes several years. By contrast, China has designated BCI as one of six strategic industries in its latest five-year plan, alongside quantum technology and humanoid robots, signaling sustained government backing and faster review cycles.
A secondary advantage cited by researchers is cultural acceptance. Meicen Sun, an information scientist at the University of Illinois Urbana-Champaign, notes that Chinese patients tend to welcome neurotechnology trials without the regulatory friction and public skepticism common in the US and Western Europe. Dong himself enrolled after seeing a television report about another Chinese patient using a BCI.
Neuracle is not alone. Chinese startups NeuroXess and StairMed have been working in BCI for years. Beinao-1, developed by the Chinese Institute for Brain Research and its affiliate NeuCyber NeuroTech, is designed for patients with movement and speech difficulties and could receive approval as early as 2028.
What this means for the field
NEO's approval signals that invasive BCIs are ready for manufacturing and large-scale clinical deployment, at least in China. Wang Shouyan, a neuroscientist at Fudan University, underscores that most prior BCI research occurred in controlled lab settings; real-world adoption has lagged. That bottleneck is now broken in one major market.
It is important not to frame this as a simple US-China race with a finish line. The two countries are pursuing fundamentally different definitions of success. The US emphasizes state-of-the-art performance and being first; China emphasizes accessibility and societal-scale solutions. Nick Ramsey, a neuroscientist at Radboud University Nijmegen, notes that BCI development has no clear endpoint, making winner-take-all framings premature.
Notably, US-China collaboration in neurotechnology persists despite geopolitical tensions. Axoft, a Cambridge-based BCI company, has partnered with a Chinese company and a Shanghai hospital to trial its device on four patients, with expansion plans ongoing.