United States

The FDA cleared the Ceribell Monitor on June 30, 2026, finding it substantially equivalent under submission number K261101 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. It is one of several Ceribell clearances in the same period; the product line is built around rapid reduced-montage setup for bedside recording in emergency and critical care.

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.

Researchers transferred dexamethasone-loaded titania nanotube arrays (TNA) onto a mechanically adaptive polymer nanocomposite (NC) substrate and, in a mouse model, compared four implants — silicon, NC, TNA-NC Empty and TNA-NC DEX (10 mice per group) — for neuroinflammation around intracortical microelectrodes at 2 and 4 weeks. At 2 weeks the gene-expression profiles were broadly similar, reflecting an early acute injury response; by 4 weeks the patterns diverged, with NC-based implants showing fewer differentially expressed neuroinflammatory genes than rigid silicon, led by TNA-NC Empty, while the dexamethasone group showed no additional benefit, suggesting drug delivery still needs optimization. The authors conclude that adding a TNA layer to flexible materials promotes resolution of the neuroinflammatory response at 4 weeks.

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.

Using implantable brain-machine interface (iBMI) data from a non-human primate two-dimensional finger task, the study tests whether brain-muscle synergies improve decoding performance and generalization. Principal component analysis (PCA), demixed PCA (dPCA) and non-negative matrix factorization (NMF) all compressed brain-muscle data effectively with minimal decoding-accuracy loss, but none improved performance through denoising or enhanced cross-task generalization. The authors conclude that extracting synergies alone does not yield a better or cleaner control space for linear decoding, and call for larger samples and more muscle channels.

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.

Researchers have found that whether people can learn to control a device with their thoughts may depend on whether the control scheme follows the brain's own activity patterns. Participants lying in an MRI scanner controlled a video game avatar in real time by modulating activity in brain regions responsible for spatial navigation. When the researchers then changed the mapping between brain activity and avatar movement, participants could readjust and regain control if the new mapping fell along directions in which their brain activity already varied widely, known as the intrinsic manifold; when the mapping departed from that structure, they never learned it. The researchers say the principle could be used to design BCIs that are easier to learn.

A study published in Computers in biology and medicine applies cross-frequency bispectral analysis to nonlinear EEG activity during the planning and execution of natural reach-to-grasp movements. The researchers extracted magnitude- and phase-based features from complex bicoherence matrices and assessed them through classification, permutation-based feature selection, and within-subject statistics. Execution showed stronger nonlinear coupling than planning, led mainly by beta- and gamma-driven interactions. Decoding precision versus power grasps performed similarly across the two stages, suggesting that grasp-type representations emerge during planning and persist into execution. Compared with conventional analytical baselines, bispectral features provided consistent advantages for grasp-type discrimination and multiclass classification. The findings offer a new set of motor-decoding features for future brain-computer interface and neuroprosthetic research.

Onward Medical said the first participant in its global Empower BP pivotal study was enrolled and implanted with the investigational ARC-IM system at Craig Hospital in Denver during the first quarter of 2026. The randomized, double-blind, sham-controlled trial is evaluating management of blood-pressure instability after spinal cord injury across about 20 planned centers. Empower BP is not an upper-limb BCI trial, and the first implant did not take place in the Netherlands.

ChatBCI-Assist integrates a locally deployed LLM with adaptive stopping, achieving record P300 speller online ITR of 105.2 bits/min and 30.7 CPM in semantic spelling.

Johns Hopkins University has launched the INTENT clinical trial to evaluate the safety and preliminary efficacy of an implantable device that records and stimulates different brain areas, enabling adults with disabling paralysis to control assistive devices and receive feedback. The trial is now recruiting participants with conditions including tetraplegia, ALS, brain stem stroke, and spinal cord injury. Johns Hopkins is a leading U.S. research university whose medical school is renowned in neuroscience. The trial was first posted on ClinicalTrials.gov on April 13, 2026, and is currently recruiting.

Two people with tetraplegia typed on a virtual two-handed QWERTY keyboard simply by attempting finger movements, which electrodes implanted in the brain decoded into keystrokes. Typing speed was set by the users and reached 110 characters per minute, or 22 words per minute, with a word error rate of 1.6%, which the authors say resembles able-bodied typing accuracy. Accurate decoding required as few as 30 calibration sentences, and a 5-gram language model improved sentence output. One participant has amyotrophic lateral sclerosis (ALS) and the other a spinal cord injury.

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.

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.

A Neurosurgical Focus paper tested Precision Neuroscience's 1,024-channel Layer 7 micro-ECoG array in four awake-craniotomy patients. Four-word speech classification reached 77.5% accuracy and four-direction cursor classification reached 78% to 84%, with no device-related adverse events reported during the procedures. The small, short intraoperative study was a feasibility test rather than a pivotal motor-restoration trial.

Neuralink said its clinical trials worldwide now include 21 participants. After making surgical and postoperative changes in response to thread retraction in the first recipient, the company reported higher signal quality in 18 of the next 20 participants. The figures come from a company update rather than a peer-reviewed clinical report.

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.

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.

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 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.