By Neurotech Reports Staff
November 5, 2026 | Ceribell gains FDA clearance for quantitative EEG trending software; Epiminder enrolls 100th patient in DETECT epilepsy study; Fareon publishes Long COVID trial results for its at-home magnetic therapy headset; Lund University begins clinical testing of High Definition Brain Stimulation electrodes; an injectable, easy-to-remove helical wire electrode drives tibial nerve stimulation through the skin in pigs; Firefly partners with NeuroSigma on pediatric ADHD treatment access; Phosphoenix raises €1.3 million for visual neuroprosthetic; and more.
Beacon Biosignals announced a partnership with Project Sleep, a patient-led nonprofit focused on sleep health, sleep equity, and sleep disorders, to reach people with idiopathic hypersomnia and narcolepsy earlier in their diagnostic journeys. People with idiopathic hypersomnia wait an average of 8 to 11 years for a diagnosis, and people with narcolepsy type 1 wait 4 to 11 years, during which they are often misdiagnosed with major depressive disorder or obstructive sleep apnea. Through the partnership, the organizations will identify undiagnosed patients, support diagnosed patients with better treatment pathways, and work to shorten the time to diagnosis. Beacon will run patient focus groups with Project Sleep to gather input on the testing experience and inform its national home sleep testing network, which supports enrollment in clinical research. Press release.
Epiminder announced that it has enrolled the 100th participant in DETECT (Diagnosing Epilepsy To EffeCT change), its prospective, randomized, controlled, blinded, multicenter U.S. study of the Minder System in patients with drug-resistant epilepsy. The study is evaluating whether continuous subscalp EEG monitoring with Minder improves clinical decision-making for patients whose prolonged EEG monitoring has been inconclusive. DETECT is designed to enroll up to 210 participants across up to 25 U.S. sites, with a six-month primary follow-up period; 22 centers are currently enrolling. The company reached the milestone ahead of its November target, expects to reach 125 participants by December 2026, and remains on track to complete enrollment by the end of the first half of 2027. Press release.
Lund University announced that its High Definition Brain Stimulation (HDBS) electrode technology is being evaluated in a clinical trial at Skåne University Hospital. HDBS uses 30 soft, flexible microelectrodes, each thinner than a strand of hair, that are guided into position through tiny gelatine microchannels that then dissolve. The early feasibility study will include up to 12 patients with Parkinson’s disease or essential tremor who are already scheduled for conventional deep brain stimulation (DBS). Researchers will assess whether HDBS can produce therapeutic effects with minimal side effects and will map the brain’s response to stimulation to build a three-dimensional map that helps neurosurgeons place the permanent DBS electrode. Neuronano AB is supporting regulatory compliance for the experimental device. Press release.
A study published in Neuromodulation: Technology at the Neural Interface (DOI: 10.1016/j.neurom.2026.09.007) evaluated an injectable helical microwire structure electrode (HMSE) for tibial nerve stimulation in pigs. The design uses only two passive implanted components, a helical microwire lead and a small subcutaneous collector, with no wires crossing the skin. Stimulation is delivered through the skin by standard surface TENS electrodes placed over the collector. Researchers placed the electrodes beside the tibial nerve under ultrasound guidance, similar to clinical posterior tibial nerve stimulation, and tested stimulation for up to eight weeks. The implanted electrodes produced limb motor responses at significantly lower thresholds than surface stimulation alone, and the devices were removed at the study endpoint using a simple fluoroscopy-guided procedure. Paper.
Spark Biomedical announced three executive appointments as it works to expand multi-channel sales, scale manufacturing capacity, and build financial and governance systems. Ric Peterson, formerly EVP, CFO and Treasurer of Medicis Pharmaceutical, has been named Chief Financial Officer. Tom Futch, most recently CCO at Little Otter Health, joins as Executive Vice President of Growth and will lead commercial growth across public-sector, hospital, and defense/first-responder channels. Jeff Jones, who has served as COO at Neuronetics, Cutera, and other device companies, becomes Executive Vice President of Manufacturing Operations and will scale production for Sparrow Ascent, HAWK, and the company’s transcutaneous auricular neurostimulation (tAN) portfolio. The company also promoted Amy Gaston to Vice President of Marketing. Press release.
Bridge Neurotech and Butterfly Network announced a research and development agreement under which Bridge will license Butterfly’s Ultrasound-on-Chip technology through the Butterfly Embedded program to pursue a fully non-invasive brain-computer interface (BCI). Bridge, which emerged from stealth with the announcement, is developing a functional ultrasound imaging (fUSI) platform with AI-based neural decoding, aiming to image and decode brain activity through the skull without surgery or implants. The multi-year agreement includes payments to Butterfly for technology access and development milestones, along with commitments by Bridge to purchase Butterfly hardware. Bridge also announced that its first human research study is enrolling participants in Redwood City, California. The company is backed by General Catalyst, reMind Capital, Sunflower Capital, and Scott Sandell. Press release.
Inspire Medical Systems announced that the American Medical Association CPT Editorial Panel has approved a new set of Category I Current Procedural Terminology codes that describe and include the Inspire V system. The codes address implantation of a single lead and an implantable pulse generator and are scheduled to take effect January 1, 2028. With the codes established, the Centers for Medicare & Medicaid Services will conduct its standard valuation process, which typically includes review by the AMA Relative Value Scale Update Committee. Inspire expects CMS to publish proposed valuations in July 2027 and final valuations in November 2027. The application was supported by the American Academy of Otolaryngology-Head and Neck Surgery, the American Academy of Sleep Medicine, and the International Surgical Sleep Society. Press release.
Fareon announced the publication in Brain Communications (DOI: 10.1093/braincomms/fcag364) of results from a randomized, triple-blind, sham-controlled trial of its Microtesla Magnetic Therapy (MMT), delivered through the noninvasive Fareon Restore headset, in patients with cognitive impairment due to Long COVID. The study was led by investigators at the Icahn School of Medicine at Mount Sinai. Participants self-administered treatment at home twice weekly, with full protocol adherence and no device-related adverse events. Those receiving active MMT showed improvements in working memory, verbal learning, processing speed, and emotional well-being compared with the control group, and benefits strengthened between the end of treatment at week four and week eight. Fareon plans larger studies, including the pivotal RECLAIM trial. Press release.
Science Corporation announced 36-month follow-up data from its pivotal PRIMAvera trial of the PRIMA BCI retinal implant in patients with geographic atrophy due to age-related macular degeneration. The trial implanted 38 patients across 17 sites in five European countries; at 36 months, 27 were evaluable for safety and 18 for efficacy. Patients showed a mean improvement of 29 letters on the ETDRS chart, up from 24.5 letters at 12 months, and 14 of 18 gained at least 15 letters. No new safety signal emerged between months 12 and 36, and natural vision in the implanted eye remained stable. The results were presented at the 26th EURETINA Congress in Vienna. PRIMA is available in Europe and the UK and pending FDA approval. Press release.
NeuWire Medical announced that the FDA has approved its Investigational Device Exemption application for STROKE-REWIRE, a pivotal study of the ReWire Vagus Nerve Stimulation System in patients with chronic ischemic stroke and upper-limb dysfunction. ReWire combines a miniaturized, wireless, battery-free implant with closed-loop technology that monitors limb function and automatically pairs vagus nerve stimulation with successful rehabilitation movements. The prospective, multicenter, randomized, sham-controlled study will enroll up to 135 participants at up to 12 U.S. sites, with initiation expected in the first half of 2027. The primary efficacy endpoint is change in Fugl-Meyer Assessment–Upper Extremity score after 18 in-clinic rehabilitation sessions, and participants will be followed for two years. Press release.
Nyxoah announced the appointment of Liam Kelly as Chief Executive Officer, effective October 1, 2026, succeeding Olivier Taelman. The appointment reflects the company’s evolution into a U.S.-focused commercial organization following FDA approval and the U.S. launch of Genio, its hypoglossal neurostimulation therapy for obstructive sleep apnea. Kelly brings more than 25 years of leadership experience. He served as Chairman, President, and Chief Executive Officer of Teleflex until January 2026, having led the company as CEO from January 2018 and as Chairman from May 2020. He joined Teleflex in 2009 and previously spent ten years in senior management roles at Hill-Rom Holdings. He is also a director of Enovis. Press release.
Ceribell announced that the FDA has granted 510(k) clearance for new software for the Ceribell System that converts raw EEG data into trends at the bedside. The update adds Alpha-Delta Ratio and Relative Alpha trending to help detect early signs of brain distress and reduced blood flow in high-risk patients such as those with aneurysmal subarachnoid hemorrhage; burst suppression monitoring to help clinicians adjust sedation when treating severe ongoing seizures or brain swelling; and amplitude-integrated EEG for long-term background monitoring in the NICU and adult ICU. The clearance carries no age restriction. The features are expected to be delivered through an automatic software update in the first half of 2027. Press release.
Firefly Neuroscience and NeuroSigma announced a strategic partnership to expand clinician awareness of and access to NeuroSigma’s Monarch eTNS System, an FDA-cleared non-drug treatment for pediatric ADHD, through Firefly’s network of Evoke clinician customers. Under the agreement, Firefly will introduce the device to psychiatry, neurology, and behavioral health practices that use its FDA 510(k)-cleared, AI-powered Evoke EEG/ERP platform and will support clinician education, while NeuroSigma will provide clinical training, prescribing support, and product fulfillment through its specialty pharmacy partner. The prescription-only Monarch device delivers mild external trigeminal nerve stimulation through a forehead patch while a child sleeps and is cleared as a monotherapy for children ages 7 through 12 not taking prescription ADHD medication. Press release.
Phosphoenix announced that it has completed a €1.3 million financing round to prepare for a first-in-human clinical study of its visual neuroprosthetic system for people with profound blindness. Existing investors TTT Medtech Fund, managed by 819 Capital; FIRST Fund, managed by BioGeneration Ventures; and Innovatiefonds Noord-Holland participated, with ROM InWest joining as a new investor. The company’s prosthesis stimulates the lateral geniculate nucleus in the brain’s visual pathway using its Fountain Probe, a high-density neural interface with more than 1,000 microelectrodes, paired with camera glasses and an AI-driven pocket processor. Phosphoenix is preparing the study with Amsterdam UMC and is working toward a Series A financing. Press release.
