The last fortnight saw a flurry of data releases. Results were published across nearly every category, from Brainsway's 12-month durability figures on accelerated TMS to Saluda's three-year closed-loop outcomes. We also saw two clean 510(k) clearances with UNEEG's implantable long-term EEG monitor and Oculogica's 90-second sideline concussion tool, both pushing objective measurement closer to the point of care.On the BCI side, two of the big names everyone tracks kept moving. Neuralink reportedly lined up Samsung to build its next-generation implant chip, while Paradromics completed its long-awaited first chronic human implant.Beyond clinical progress, there were funding rounds that are worth a closer read than their size suggests. WISE's electrode raise, Somareality's eye-tracking Series A, and Nyxoah's big $110M financing each say something about where the capital and the risk sit right now. We take a closer look at Somareality in this issue's Double Click.
A report out of South Korea indicates Samsung has secured an R&D contract to manufacture Neuralink's fourth-generation implant chip, with first test chips reportedly shipped and full production scheduled for 2027. Locking in a large-scale foundry partner signals preparation for higher-volume implantation, also seen through manufacturing moves in Austin, though not many details have been shared so far.
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Paradromics completed the first surgical implantation of its Connexus brain-computer interface in the FDA-approved Connect-One feasibility study at University of Michigan Health. The study is among the first to target speech restoration and builds on a temporary implant that the same surgical team placed during epilepsy research in 2025. It is the first chronic Connexus implant since Paradromics secured its IDE in November 2025.
New 36-month data from Saluda's EVOKE program continues to show durable outcomes for its closed-loop spinal cord stimulation system. 90% of patients who responded after three months remained responders after three years. The Evoke system is the only platform that reads the spinal cord's own evoked response to stimulation, the ECAP, adjusting stimulation more than 100 times per second to keep therapy on target.
Brainsway presented its first 12-month durability data for the SWIFT accelerated Deep TMS protocol at the Clinical TMS Society annual meeting. Drawn from patients who completed the company's FDA pivotal trial, the prospective follow-up reported a remission rate above 80% one year after treatment, alongside a decline in severe functional impairment. SWIFT reduces clinic visits by around 70% compared to the standard protocol.
Nervonik completed a first-in-human feasibility study demonstrating nerve sensing during peripheral nerve stimulation. The system captured evoked compound action potentials and muscle potentials during active stimulation, markers the company intends to use for future biosensing-enabled features such as closed-loop therapy.
Nyxoah completed approximately $110M in June financing, combining a $95M equity raise with a €13.8M second tranche from its European Investment Bank loan facility. The capital addresses a pressing funding need. As of March 31st, the company held €25.9M in cash against a quarterly operating loss near €20M, with management flagging going-concern doubt and a runway extending only into Q3 2026. The new financing is aimed primarily at the US commercial launch of Genio, its hypoglossal nerve stimulation system for obstructive sleep apnea, which received FDA approval in August 2025.
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The FDA cleared Wave Neuroscience's MeRT system as an adjunct treatment for PTSD. MeRT uses a patient's own EEG-derived brain activity to tailor the delivery of transcranial magnetic stimulation, an individualized approach to dosing that distinguishes it from fixed-protocol TMS. Clearance was supported by a double-blind, randomized, multi-site trial run with Texas A&M Health and builds on the company's 2024 Breakthrough Device designation. It is the latest in a recent run of PTSD neuromodulation clearances, following GrayMatters Health's neurofeedback-based Prism and Neurovalens' vestibular-stimulation device, a sign of a more active regulatory path for brain-based PTSD treatment.
UNEEG Medical received FDA 510k clearance for its EpiSight system, advancing its implantable, long-term EEG monitoring platform in the US. The subcutaneous device captures continuous seizure data outside the clinic, addressing the gap between brief in-clinic EEG and patient-reported seizure diaries in epilepsy management. The clearance follows the company's earlier Breakthrough Device designation and CE mark and opens a US commercial pathway for ultra-long-term monitoring.
Oculogica secured FDA 510k clearance for SNAP, moving its eye-tracking technology closer to the point of initial concussion assessment. The portable infrared tool measures eye movements during a short visual task and combines them with self-reported symptom severity. Its 15-to-25 age label positions high school and college sports as the clearest early market. SNAP extends a product line that began with EyeBOX, cleared via De Novo in 2018.
Somareality closed an oversubscribed Series A of more than €3M led by Catalyst Romania, with existing investors MT-Lab, RDY Ventures, Moondust Ventures, and Gateway Ventures participating. The Vienna-based startup builds hardware-agnostic algorithms that infer cognitive states such as load, attention, and fatigue from eye-tracking data, generating digital biomarkers as an alternative to EEG and fNIRS. The capital is directed at expanding its B2B segments, funding longitudinal cognitive-health studies, and a planned move into the consumer space.
Cognision published a study reporting that ketamine produces divergent brain effects across patients and showed that the direction of response can be predicted using EEG. The finding positions EEG as a stratification tool for identifying likely responders before treatment begins, a recurring theme in biomarker-guided psychiatry. For Cognision, which builds an EEG-based assessment platform, the work reinforces a measurement role within the expanding interventional psychiatry space.
A new peer-reviewed pilot of Vielight's intranasal-transcranial photobiomodulation reported improvements in memory, overall cognition, and brain connectivity in adults with mild cognitive impairment. Published in the Journal of Alzheimer's Disease, the randomized study of 20 participants also noted changes in biomarkers tied to inflammation and cellular energy production, with analysis conducted by an independent team. The results follow shortly after Vielight announced a new partnership with UFC fighter Ilia Topuria.
Psyonic is collaborating with ABB Robotics to improve how robots handle delicate, variable objects. The partnership pairs Psyonic's EMG Ability Hand, a prosthetic with touch sensing and a soft, compliant grip, with ABB's GoFa collaborative robot. Because the same hand can be worn by a person or mounted on a robot, it can gather real manipulation data from human use and feed that back into training robots, part of the wider push to bring physical AI into industrial robotics.
WISE closed an oversubscribed €30M Series D. The Italian company builds soft, flexible implantable electrodes designed to sit against tissue more closely than the rigid versions used in most neuromonitoring, neuromodulation, and BCI devices. The funding takes its lead implant, Heron, toward certification and a first-in-human study, alongside scale-up of its wider electrode range.
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