United States

Nova Southeastern University researchers combine intracranial ECoG network features with a support vector machine and Bayesian updating for real-time continuous seizure risk forecasting.

Researchers at Coherence Neuro Global, Inc. and other institutions have used implanted neural interfaces to track glioma growth in freely behaving mice over time. Across several mouse strains and glioma models, tumor progression went with elevated gamma-band activity in the tumor microenvironment, and machine learning models read tumor burden off the chronic recordings, with gamma trajectories predicting individual growth rates. The work was posted to bioRxiv on July 9, 2026, and has not been peer reviewed.

Harvard Medical School researchers report that spectral analysis of facial movements in rodents predicts both cortical activity and performance on brain-machine interface tasks, a possible biological basis for better neural prosthetic control. The work is a preprint and has not been peer reviewed.

Neurosom announced it has been granted a patent for a method that combines Bayesian statistical modeling with personalized EEG data and brain atlas models to achieve "super-resolution" in locating the origins of brain electrical activity, potentially improving the guidance of transcranial electrical stimulation (TES). The patent, titled "Method for Bayesian Super-Resolution of Electroencephalographic Source Analysis and Transcranial Electrical Stimulation" (US Pat. No. 12,663,866), was announced on July 9, 2026.

A preprint shows that functional ultrasound imaging (fUSI), read through an acoustically transparent cranial-window implant, reliably resolved multi-body-part and single-digit movement encoding in one participant's primary sensorimotor cortex, with maps consistent with classical somatotopy and single-trial decoding supported across sessions; analysis of key decoding voxels suggested different Brodmann areas encode single-digit movement differently. The researchers argue fUSI can map motor representations at submillimeter resolution, filling a key gap in humans between invasive electrophysiology and non-invasive blood-flow imaging; the work has not been peer reviewed.

Microsoft and INBRAIN Neuroelectronics said they will work together on AI-driven brain-computer interface therapeutics, pairing INBRAIN's graphene-based neural interfaces with Microsoft's cloud computing and data infrastructure to speed development of treatments for neurological disorders. INBRAIN, a Spanish neurotechnology company, says its system combines graphene electrodes with AI algorithms to read and modulate brain signals with high precision, on a platform it describes as bringing together neuroscience, bioelectronics and AI.

INBRAIN Neuroelectronics has announced a partnership with Microsoft to apply the software company's large language models and data analytics tools to make its brain-computer interfaces adapt in real time. INBRAIN builds graphene-electrode BCIs for neurological disorders, spanning invasive and non-invasive applications, and recently partnered with the Mayo Clinic to speed clinical development and commercialization of its BCI therapies, with investigator-led clinical research under way.

Barcelona-based INBRAIN Neuroelectronics said it will work with Microsoft on AI for neurology and brain-computer interfaces, combining INBRAIN's neuroscience, bioelectronics and AI work with Microsoft's cloud and AI infrastructure. INBRAIN's graphene-based neural interface is being developed as an adjunctive therapy for Parkinson's disease; it received FDA breakthrough device designation in 2023 and entered its first-in-human study in the fall of 2025.

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 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.

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.

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.