United States

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.

Synchron raised a $200 million Series D led by Double Point Ventures, taking its total funding to $345 million. The company plans to use the capital to commercialize its Stentrode endovascular BCI, prepare pivotal trials and expand its AI and engineering teams. Synchron said 10 people with paralysis had received the implant in U.S. and Australian trials at the time of the announcement.

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.

A Neuron paper describes Neuropixels Ultra, which packs 6,144 switchable recording sites at 6-micrometer center-to-center spacing while reading 384 channels simultaneously. In mouse visual cortex recordings, neuronal yield increased by more than twofold. The study also improved subcellular signal detection and cell-type classification, but it did not report simultaneous recording from 10,000 neurons.

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.

Synchron reported 12-month results from the U.S. COMMAND early feasibility study in six people with severe chronic bilateral upper-limb paralysis. All participants met the primary safety endpoint of no device-related serious adverse event causing death or permanent increased disability, and motor-intent signals were converted into digital actions throughout the study. The disclosure was not a two-year pivotal-trial report.

California's SB 1223, enacted in 2024, amended the CCPA to classify neural data as sensitive personal information alongside genetic and biometric data.

Neuralink said thread retraction in its first PRIME participant temporarily reduced BCI performance before the threads stabilized and performance recovered. For the second implant, the team reduced brain motion during surgery and narrowed the gap between the implant and the brain surface. The company reported no thread retraction in the second participant at the time, but it did not publish channel-attrition rates or a formal interim safety report.

The University of Miami has opened a clinical trial testing whether a brain-computer interface can decode upper-limb motor intention from EEG or ECoG and use it both to trigger epidural spinal cord stimulation (ESCS) and to control assistive devices in people with spinal cord injury. The study was first posted on August 1, 2024, and is recruiting.

The University of Miami is recruiting participants with incomplete spinal cord injury for a walking rehabilitation trial combining a brain-computer interface with transcutaneous spinal cord stimulation. The trial is registered on ClinicalTrials.gov as NCT06406855 and is currently recruiting.

Colorado's HB24-1058, signed in 2024, brought neural data under the state privacy act's sensitive-data protections, a first in the United States.

A randomized clinical trial called BCI-REHAB compared an at-home brain-computer interface (BCI) therapy system with a home exercise program for upper-extremity rehabilitation in chronic stroke survivors. The trial, conducted in the United States, was first posted on July 28, 2023, last updated on August 12, 2026, and has a status of completed. The study used Neurolutions' IpsiHand Upper Extremity Rehabilitation System, which reads motor intentions via scalp electrodes and drives an exoskeleton hand device to facilitate repetitive hand movement training. The trial aimed to evaluate the efficacy of BCI-based therapy versus standard exercise therapy and assess the potential for meaningful motor improvement in a home setting. The trial covered conditions including stroke, hemiparesis, spasticity as a sequela of stroke, and chronic stroke survivors with a plegic hand, but results have not yet been published.

The University of Texas at Austin has registered a study on ClinicalTrials.gov, NCT05907343, testing whether non-invasive stimulation can strengthen cognitive control in older adults, enrolling both people with cognitive impairment and people without it. It asks whether theta burst stimulation, a form of transcranial magnetic stimulation, can restore a range of cognitive functions, and whether delivering it in closed loop, timed to ongoing brain activity rather than on a fixed schedule, changes the result.

The US Bureau of Industry and Security announced a two-day hybrid BCI conference with industry and academic experts, following its 2021 export-control inquiry.

The FDA granted Breakthrough Device designation to Blackrock Neurotech's MoveAgain BCI System on November 16, 2021. The investigational system combines an implanted array, neural decoding and wireless output with the goal of allowing people with severe paralysis to control digital and assistive devices. The designation can expedite development and review but is not market approval.

The US Bureau of Industry and Security published a 2021 advance notice seeking comments on export controls for BCI as an emerging technology, focused on national security.

The VA Office of Research and Development is conducting a clinical trial to characterize proprioceptive sensations in the missing limb of upper limb amputees using nerve stimulation and to develop advanced controllers for moving a prosthesis. The trial uses Functional Electrical Stimulation (FES), applying small electric currents to the nerves, and tests different stimulation placements. The trial is registered as NCT04947462 and is currently recruiting.

The FDA issued final guidance in 2021 on implanted brain-computer interface (BCI) devices for patients with paralysis or amputation, covering nonclinical testing and clinical study design.

Vanderbilt University Medical Center has developed a method that uses post-operative CT scans and image processing to determine the physical relationship between cochlear implant electrodes and the neural interface, allowing sub-optimally positioned electrodes to be switched off for a customized map. Cochlear implants are surgically implanted devices that restore hearing by electrically stimulating the auditory nerve, and their programming has traditionally ignored where the electrodes actually sit. The trial tested whether this individualized image-guided programming improves hearing and speech outcomes in pediatric recipients, with hearing measures collected at baseline, 12 months and 24 months; it has been completed, but results have not been posted.

Johns Hopkins University is conducting an early feasibility study to evaluate the safety and efficacy of the Bidirectional Cortical Neuroprosthetic System (BiCNS). The system comprises NeuroPort Microelectrode Array Systems, NeuroPort Electrodes (Sputtered Iridium Oxide Film), Patient Pedestals, the NeuroPort BioPotential Signal Processing System, and the CereStim C96 Programmable Stimulator. The trial enrolls patients with tetraplegia and quadriplegia and is currently recruiting.