Policy & Regulation

The FDA cleared Universal Brain's UB ERP System on June 30, 2026, finding it substantially equivalent under submission number K253767 through the traditional 510(k) pathway. The agency classifies it as Non-Normalizing Quantitative Electroencephalograph Software, a Class II device under regulation 882.1400, with neurology as the assigned review panel. Event-related potentials are obtained by averaging EEG time-locked to stimuli; components such as P300 serve both clinical assessment and the classic paradigms behind noninvasive BCI spellers.

The FDA approved a premarket approval (PMA) supplement, S039, from Saluda Medical Pty, Ltd. on June 29, 2026, covering the CAP24 Paddle Lead, Passing Elevator, Evoke CLS (REF 3042), Clarity Programming Application (CPA) and RECAP Viewer. The supplement is a labeling change touching indications, instructions for use, shelf life and trade name rather than an original approval of a new device; the products carry the generic name 'stimulator, spinal-cord, totally implanted for pain relief.' Saluda Medical is an Australian company whose Evoke system is one of the few closed-loop spinal cord stimulators on the market.

Guangdong issued a provincial BCI action plan targeting 100 new tech companies, 200 BCI hospital wards and a ten-billion-yuan industry by 2030.

The FDA cleared the Ceribell Neurology Review Software on June 24, 2026, finding it substantially equivalent under submission number K260998 through the traditional 510(k) pathway. The agency classifies it as Automatic Event Detection Software for Full-Montage Electroencephalograph, a Class II device under regulation 882.1400, with neurology as the assigned review panel. The category covers software that automatically flags events within full-montage EEG recordings, surfacing candidate segments from long records for clinician review.

8 Chinese ministries jointly issued a policy document explicitly promoting the integration of AI with brain-computer interface, AR, VR, and MR technologies.

The General Office of China's Anhui Provincial People's Government issued the Action Plan for Accelerating Brain-Computer Interface Technology and Industry Development in Anhui (2026-2030) on June 15, 2026, document number Wan Zheng Ban Mi [2026] No. 24. Its spatial layout assigns Hefei the role of innovation origination and talent attraction, Bengbu the fabrication and validation of key components on the strength of its smart sensor industry plus a new Longhu Laboratory, and Wuhu clinical translation through a national regional medical centre and a brain science institute at Wannan Medical College. The first main task backs the University of Science and Technology of China in leading a research institute with Chinese Academy of Sciences partners. Targets fall in 2028 rather than 2027, covering at least ten application scenarios, three approved invasive clinical trials, five systems and three backbone firms.

The FDA cleared Neuroelectrics Barcelona's Enobio Dx line, in 8-, 20- and 32-channel models, on June 13, 2026, finding it substantially equivalent under submission number K261604 through the special 510(k) pathway. The agency classifies it as a Full-Montage Standard Electroencephalograph, a Class II device under regulation 882.1400, with neurology as the assigned review panel. Neuroelectrics is known in neuromodulation and BCI research for noninvasive EEG acquisition and transcranial electrical stimulation hardware.

The FDA cleared VoxNeuro's Cognitive Function Neuroimaging (cfNI) Software, version 1.0.0, on June 12, 2026, finding it substantially equivalent under submission number K253015 through the traditional 510(k) pathway. The agency classifies it as Normalizing Quantitative Electroencephalograph Software, a Class II device under regulation 882.1400, with neurology as the assigned review panel. Normalizing quantitative EEG software compares an individual's EEG metrics against a reference population database before reporting, supporting objective assessment of cognitive function.

The General Office of China's Tianjin Municipal People's Government issued the Action Plan for Promoting Innovative Development of Brain-Computer Interfaces in Tianjin (2026-2030), document number Jin Zheng Ban Fa [2026] No. 8, dated May 26, 2026 and released on May 28. All product targets sit on the non-invasive track, while invasive systems are covered only by milestones for entering registration trials and winning market approval. By 2027 Tianjin wants two to three national-level innovation platforms, more than five non-invasive products in clinical use, more than ten new products across elderly care, education, entertainment, smart living and advanced manufacturing, 50 innovative firms, one to two national standards, and three to five industry funds. By 2030 it targets more than ten non-invasive products in large-scale clinical use, market approval for invasive products, and a fund cluster exceeding 10 billion yuan.

The Jiangxi Provincial Health Commission in eastern China issued Guidelines for Ethics Review of Brain-Computer Interface Clinical Research Projects on May 26, 2026, document number Gan Wei Ke Jiao Fa [2026] No. 8, providing implementing detail for the mutual recognition mechanism proposed in the province's November 2025 BCI measures. For multicentre projects the lead institution's ethics committee conducts the first full review; participating institutions should finish within 10 working days of receiving complete materials and examine only local research conditions, staff qualifications and the informed-consent process; and the lead institution must file with the provincial medical ethics expert committee within 10 working days. Invasive projects treating neurological or psychiatric disease need provincial committee review within 20 working days, with an opinion issued within a further seven.

The FDA cleared Zeto's New Wave System on March 13, 2026, finding it substantially equivalent under submission number K260455 through the special 510(k) pathway. The agency classifies it as a Full-Montage Standard Electroencephalograph, a Class II device under regulation 882.1400, with neurology as the assigned review panel. That category covers standard electroencephalograph hardware acquiring a complete montage of scalp channels.

Nine Jiangsu provincial departments in eastern China led by the Department of Industry and Information Technology issued the Action Plan for Innovative Development of the Brain-Computer Interface Industry in Jiangsu in March 2026, implementing national guidance from seven ministries. Its most distinctive provision covers industrial deployment, directing firms in hazardous materials, nuclear power, mining and electricity to pilot BCI systems in safety management and deep-sea and deep-pit operations, sectors no other provincial document names. Headline goals are at least two provincial clusters by 2027 and two to three leading enterprises by 2030. Its quantitative targets sit at the end of 14 tasks and all fall in 2030, including at least 15 programme projects, 15 key technology tasks, about 10 innovation platforms, 30 certified flagship products, 20 registered medical devices and a dataset of at least 20,000 samples.

Four Chinese ministries jointly issued science-technology insurance guidance, listing BCI alongside AI and quantum technology as key sectors for dedicated insurance products.

The FDA cleared Clouds of Care's PreOp v3 on February 13, 2026, finding it substantially equivalent under submission number K252565 through the special 510(k) pathway. The agency classifies it as Source Localization Software for Electroencephalograph or Magnetoencephalograph, a Class II device under regulation 882.1400, with neurology as the assigned review panel. Source localization software infers the intracranial origin of signals from scalp-recorded electric or magnetic fields, a step in neurosurgical planning such as presurgical localization of epileptic foci.

Alphatec Spine's SafeOp 3 neural monitoring system received FDA 510(k) clearance on January 11, 2026 for intraoperative neural monitoring. The device is regulated as a Class II "Stimulator, Electrical, Evoked Response" under regulation number 882.1870, and the clearance came through the traditional 510(k) pathway, with the FDA finding the device substantially equivalent to a predicate device. Alphatec Spine, a maker of spinal surgery devices and technologies, adds SafeOp 3 to its neural monitoring portfolio; the system is intended to let surgeons assess nerve function in real time during procedures and lower the risk of nerve injury.

BrainCo's FocusXin Medical Edition combines a single-channel prefrontal EEG device registered as 浙械注准20232071898 with ADHD rehabilitation software registered as 浙械注准20252211934. The Class II system is intended for supplementary rehabilitation training in children aged 6 to 12 with ADHD. Its defined medical use should not be generalized into approval for an unspecified consumer BCI product.

The FDA cleared the Ceribell Delirium Monitor System on December 8, 2025, finding it substantially equivalent under submission number K251936 through the traditional 510(k) pathway. The agency classifies it as a Neuropsychiatric Interpretative Electroencephalograph Assessment Aid, a Class II device under regulation 882.1440, with neurology as the assigned review panel. The category covers devices that derive neuropsychiatric assessments from EEG signals; Ceribell's earlier products in this line target seizure monitoring in emergency and intensive care settings.

Tongji Hospital in Wuhan implanted a 64-channel high-throughput flexible electrode array made by Wuhan Neuracom into a 31-year-old man paralysed by a spinal cord injury on 26 November 2025. The procedure was charged under the country's first BCI medical service price schedule, issued by Hubei's healthcare security bureau in March 2025, which sets implantation at 6,552 yuan. China's National Healthcare Security Administration calls it the first BCI operation in the country carried out under a state-set price. This patient's costs were covered by research funding.

The FDA cleared Hippoclinic's HippoMind, version 1.0, on December 3, 2025, finding it substantially equivalent under submission number K251881 through the traditional 510(k) pathway. The agency classifies it as Non-Normalizing Quantitative Electroencephalograph Software, a Class II device under regulation 882.1400, with neurology as the assigned review panel. Unlike normalizing tools, non-normalizing quantitative EEG software reports an individual's own EEG metrics without reference to a population database.

The General Office of China's Jiangxi Provincial People's Government issued Several Measures for Accelerating the Development of Brain-Computer Interface Technology and Industry in Jiangxi on November 26, 2025, document number Gan Fu Ting Fa [2025] No. 29, setting out 11 measures across four areas. It was the first provincial document to follow the seven-ministry national guidance and is the only one that sets no quantitative industry targets at all. Its eleventh measure calls for implementing BCI research ethics guidelines and establishing mutual recognition of clinical research ethics review, a first among provincial documents. Other measures deploy a provincial major science and technology programme, back Ganjiang New Area in building a rehabilitation centre and a high-quality EEG dataset, and offer early regulatory engagement plus rewards for Class II and Class III innovative device approvals.

The FDA cleared Naox Technologies' NX01 on November 25, 2025, finding it substantially equivalent under submission number K251550 through the traditional 510(k) pathway. The agency classifies it as a Reduced-Montage Standard Electroencephalograph, a Class II device under regulation 882.1400, with neurology as the assigned review panel. Reduced-montage systems record with fewer electrodes than a conventional clinical montage, trading spatial resolution for faster setup and the possibility of wearable form factors.

The US Food and Drug Administration cleared Ceribell, Inc.'s Ceribell Infant Seizure Detection Software on November 21, 2025, finding it substantially equivalent under submission number K252070 via the Traditional 510(k) pathway. FDA lists it as Automatic Event Detection Software for Full-Montage Electroencephalograph, a Class II device under regulation number 882.1400, reviewed by the agency's neurology advisory committee. Neonatal EEG looks markedly different from adult morphology, which has long made automated interpretation difficult; the classification covers software that flags events automatically in full-montage recordings.

UNESCO's 43rd General Conference adopted the Recommendation on the Ethics of Neurotechnology, the first global framework, backed by 194 Member States.

The FDA cleared Persyst Development's Persyst 15 EEG Review and Analysis Software on October 31, 2025, finding it substantially equivalent under submission number K252160 through the traditional 510(k) pathway. The agency classifies it as Automatic Event Detection Software for Full-Montage Electroencephalograph, a Class II device under regulation 882.1400, with neurology as the assigned review panel. The category covers software that automatically flags events within full-montage EEG recordings for clinician review.

Nihon Kohden's EEG-1260A Neurofax system, along with its amplifier unit and photic stimulator, received FDA 510(k) clearance on October 9, 2025. The device is a Class II medical device in the neurology specialty, with software for quantitative EEG analysis. The traditional 510(k) clearance indicates substantial equivalence to a legally marketed device.

ARC-EX is a non-invasive spinal cord stimulation device used to improve hand function in people with spinal cord injury; the CE mark allows commercial sale in the EU.

The FDA cleared Forest Devices' SignalNED System (Model RE) on September 3, 2025, finding it substantially equivalent under submission number K251726 through the traditional 510(k) pathway. The agency classifies it as a Reduced-Montage Standard Electroencephalograph, a Class II device under regulation 882.1400, with neurology as the assigned review panel. Forest Devices has applied reduced-montage EEG to prehospital stroke identification, acquiring interpretable signals in settings such as ambulances.

Thirteen departments in China's Shandong province, led by the Department of Science and Technology, jointly issued the Action Plan for Scientific and Technological Innovation in the Brain-Computer Interface Industry in Shandong (2025-2027), document number Lu Ke Zi [2025] No. 50, dated May 13, 2025 and released on May 16. By 2027 the province aims for roughly 20 breakthroughs in frontier and core technologies, about 30 innovative technology SMEs, two to three high-level talent teams, and one to two specialised incubators in areas rich in research and education resources, with applications reaching medicine, industry, elderly care, education and entertainment. By 2030 it expects an initial BCI industry ecosystem. The plan organises work into six campaigns and backs Jinan and Qingdao as innovation clusters. It is the first of Shandong's two provincial BCI documents and covers the industrial side.

Eight Sichuan provincial departments in southwestern China led by the Department of Economy and Information Technology issued the Action Plan for Breakthroughs in the Brain-Computer Interface and Human-Machine Interaction Industry in Sichuan (2025-2030) on May 12, 2025. The plan is unusual in making surgical volume a headline metric, targeting 3,000 invasive BCI procedures a year by 2030, along with services for more than 100,000 patients a year with neurodegenerative disease, psychiatric conditions and drug or digital addiction, and rehabilitation device use exceeding 20,000 sessions a year. By 2027 it aims to complete development and medical device registration of three invasive and five non-invasive products, carry out the province's first invasive BCI operation, serve more than 50,000 patients a year, and cultivate 10 chain-leading firms, 100 specialised SMEs and 200 innovative smaller enterprises. Chengdu, Mianyang, Deyang and Nanchong are named as host cities.

Shanghai's science commission issued a BCI industry action plan centering on medical-grade scenarios, with a clinical timeline for invasive and semi-invasive products.