September 29, 2026 | News from around the neurotech industry including Boston Scientific’s recall of Infinion CX lead, results from a hypoglossal nerve stimulation system trial, neural implants that work without batteries, vaginally-inserted, wireless neuromodulation device, cranioplasty implant and BCI connections receive FDA clearance, new US VP of Neuromodulation for Abbott, and more.
Complete Spinal Cord Injury Patients Walk Again Using “Trunk-Mediated Control”
Researchers at Italy’s MINE Lab (a collaboration between Università Vita-Salute San Raffaele, IRCCS Ospedale San Raffaele di Milano, and Scuola Superiore Sant’Anna), led by Pietro Mortini and Silvestro Micera, report that four patients with chronic, motor-complete thoracic spinal cord injuries (AIS A/B) regained the ability to stand and walk with a walker using a commercially available epidural spinal cord stimulator. The team discovered that a small voluntary trunk movement—averaging just 9 degrees—shifts the anatomical relationship between nerves and the implanted electrodes enough to switch the stimulation’s effect between knee-extension (weight-bearing) and coordinated hip-knee-ankle flexion (stepping), letting patients themselves trigger the gait cycle without brain implants or external sensors. After four months of intensive rehabilitation, all four participants improved from a WISCI II score of 0 to 9, walked independently without body-weight support, and navigated turns, slopes, and uneven outdoor surfaces; three could also stand while using only one hand for support. None of the participants regained the ability to voluntarily contract their leg muscles — the stimulation still generates the movement — but the trunk gesture gives them a way to control it. The study was published in Med (Cell Press). Read more
CraniUS Therapeutics Receives FDA 510(k) Clearance for the CraniUS Plate
CraniUS Therapeutics received FDA 510(k) clearance for the CraniUS Plate, a patient-specific cranioplasty implant for repairing cranial defects from trauma, tumor resection, decompressive craniectomy, and other causes. The clearance, granted July 29, 2026, marks the company’s first commercially available product and is designated NeuroPASS 1, the foundational configuration of its investigational NeuroPASS platform, which the company plans to expand with features for brain access, diagnostics, and eventually drug delivery designed to bypass the blood-brain barrier. Those additional capabilities remain investigational and are not part of the cleared device. Read the full release
Bioness, OneStep Transform Mobility Rehabilitation
Bioness Medical and OneStep announced a partnership allowing clinicians to objectively measure and track patients’ gait and mobility using a smartphone, both in clinic and in daily life. The OneStep platform analyzes more than 30 gait and mobility parameters and will be included with every new Bioness L300 Go System or Portable Neuromodulation Stimulator (PoNS) purchase. In an early evaluation of more than 300 patients, functional electrical stimulation via Bioness’s L300 Go and L300 Go Plus systems produced measurable improvements in walking speed, stride length, and gait symmetry, with users of the L300 Go Plus seeing stride length increase by 5.9 cm and walking velocity improve from 0.68 to 0.74 m/s. The companies say pairing intervention with objective measurement led to 15.3% more patients continuing with clinician-recommended therapy. Read the full release
NeuroStar Integrates TMS with EHR
Neuronetics announced the integration of its TrakStar practice management platform with AdvancedMD, a cloud-based EHR, practice management, and revenue cycle platform used by more than 65,000 practitioners across 13,000 independent practices. The company says this makes NeuroStar the first TMS system to integrate with an EHR/EMR, allowing treatment data to flow into the same system practices use for scheduling, clinical records, and billing, reducing duplicate administrative work. The integration will be available to NeuroStar providers already using AdvancedMD starting in Q4 2026, and to future adopters of AdvancedMD going forward. Read the full release
Insightec Marks 10,000 Patients Treated
Insightec announced that 10,000 patients across the Europe, Middle East and Africa (EMEA) region have now been treated with its Exablate Neuro platform for essential tremor and Parkinson’s disease, with treatment volumes in the region more than doubling over the past three years. MR-guided focused ultrasound is now available at more than 62 treatment centers across 20 countries in EMEA, part of a global footprint of more than 30,000 patients treated at 226 centers worldwide. The company says access and reimbursement still vary significantly by country and is working with health authorities and patient groups to close those gaps. Read the full release
Team Tests Injectable, Battery-Free Neural Implants
A University of Florida-led research team, working with Harvard’s BIONICs Lab, is developing a needle-injectable, battery-free neural stimulator powered wirelessly by a small external wearable transmitter that conducts energy through body tissue. In rat trials, the implant reliably activated the sciatic nerve and produced muscle responses with minimal tissue response and could be removed by the patient simply by taking off the external transmitter. Unlike existing spinal or peripheral nerve stimulators, which require surgical implantation and bulky batteries, the new device is designed for same-day outpatient placement. The team is now working to halve the implant’s size ahead of human testing and is pursuing additional grants to advance the work, which builds on a 2024 NIH grant awarded to project lead Adam Khalifa. The research was published in the journal Advanced Science. Read the full release
Boston Scientific Recalls Infinion CX Lead for Spinal Cord Stimulators
The FDA identified a Class I recall—its most serious designation—after Boston Scientific advised customers to remove all unused Infinion CX Leads (Spinal Cord Stimulator System components used for chronic back and limb pain) from use or distribution. The company said the lead body may experience mechanical stress at the anchor site, potentially causing high impedance measurements or lead fractures that result in inadequate stimulation and may require lead explant and replacement. As of May 27, 2026, Boston Scientific had reported 1,081 serious injuries and no deaths tied to the issue. The recall applies to unused devices; already-implanted leads are not affected, and no additional patient monitoring beyond routine follow-up is recommended. Read the full release
Paradromics Receives FDA Approval to Expand BCI Access
Paradromics received FDA approval expanding the types of computing devices that can be used with its investigational Connexus BCI system in the Connect-One Early Feasibility Study. The approval lets Paradromics support compatible personal, internet-connected devices—such as laptops, tablets, and phones—through Convey, its user-facing system for translating decoded neural intent into communication and computer control, without needing separate FDA approval for each new device. The company says the change moves its platform beyond a company-provided computing environment toward one that can travel with users in their daily lives. Read the full release
Radial Supports Largest Brain Medicine Clinical Network
Radial announced its acquisition of the management services organization supporting Mindful Health Solutions, one of the country’s top interventional psychiatry groups, creating what the company describes as the nation’s largest network of brain medicine clinics. The combined network spans 27 clinics and more than 100 clinicians treating conditions including major depressive disorder, PTSD, OCD, suicidality, and tardive dyskinesia with treatments such as TMS, Spravato, and (in the future) psychedelic medicines, supported by Radial’s AI-enabled RadialOS platform. As part of the deal, Radial co-founder Owen Muir, MD, becomes Chief Scientific Officer, while Mindful Health Solutions’ Tobias Marton, MD, PhD, becomes Chief Medical Officer of the combined network. Read the full release
MellingMedical, ANEUVO Deliver Advanced Neuromodulation Therapy
MellingMedical announced a strategic relationship with ANEUVO to bring ANEUVO’s ExaStim Stimulation System to federal healthcare providers serving veterans, active-duty personnel, and their families. ExaStim is an FDA-cleared, non-invasive transcutaneous spinal stimulation system indicated for improving hand sensation and strength in adults with chronic, non-progressive neurological deficits from incomplete spinal cord injury, used alongside functional task practice. The device delivers stimulation through a 16-electrode flexible pad controlled via a tablet app and will now be available through MellingMedical’s federal contracting vehicles, including its ECAT, FSS, and DAPA schedules. Read the full release
BCI Study Published in Stroke
Kandu has published BCI-REHAB, the first NIH-sponsored randomized controlled trial of an at-home, noninvasive brain-computer interface therapy for chronic stroke, in Stroke: Vascular and Interventional Neurology. In the trial, 62 chronic stroke patients (mean 5.4 years post-stroke) using the FDA-cleared IpsiHand System at home for 12 weeks achieved a 4.5-point greater improvement on the Upper-Extremity Fugl-Meyer scale than a control group doing a standard home exercise program, with 55.5% of IpsiHand users reaching clinically meaningful improvement versus 9.6% of controls. The trial was stopped early for efficacy, and no serious or device-related adverse events were reported. IpsiHand pairs a noninvasive EEG headset with a wearable handpiece that assists hand movement when it detects the patient’s intent to move. Read the full release
NeuroOne Q3 2026 Financial Results
NeuroOne Medical Technologies reported fiscal third-quarter 2026 results, with product revenue up 16% year-over-year to $2.0 million and product gross margins expanding to 59.9%. The company received $2.7 million in new product orders during the quarter, outpacing shipments and growing its backlog to $1.7 million, and has now received $11.2 million in product orders for the full fiscal year. NeuroOne also announced it received ISO 13485 certification ahead of schedule to support international expansion and said its StereoCED drug delivery system is expected to be available for research and investigational clinical studies by the end of the fiscal year. Read the full release
Grey Matter Neurosciences Focuses on Treatment-Resistant Depression
Toronto-based Grey Matter Neurosciences announced treatment-resistant depression as the inaugural clinical focus for its non-invasive, focused-ultrasound neuromodulation platform, with a pilot clinical study targeting seniors and adults expected to begin in early 2027. The company also launched an online registry to support recruitment for that trial and future research. Grey Matter is commercializing focused ultrasound technology developed over the past decade by Dr. Kullervo Hynynen and his team at Sunnybrook Research Institute; the platform is designed to target deep brain structures without surgery, implants, or incisions. The device has not yet been submitted for FDA or Health Canada review and is not commercially available anywhere. Read the full release
Gary Kurdziel Joins Abbott as U.S. Divisional Vice President of Neuromodulation
Gary Kurdziel has joined Abbott as U.S. Divisional Vice President of Neuromodulation, per an announcement shared on LinkedIn. See the announcement
Nyxoah Study Meets Primary Safety, Efficacy Endpoints
Nyxoah’s ACCCESS U.S. pivotal study met its co-primary efficacy endpoints for the Genio hypoglossal nerve stimulation system in obstructive sleep apnea patients with Complete Concentric Collapse (CCC) of the soft palate — a population currently contraindicated for commercially available unilateral hypoglossal nerve stimulation in the U.S. At 12 months, the Full Analysis Set of 47 patients showed a 77.2% AHI responder rate (per Sher criteria, p<0.001) and an 87.7% ODI responder rate (p<0.001), with zero device-related serious adverse events reported through 12 months. Enrollment closed ahead of the planned maximum of 106 patients. Genio is already CE-marked for CCC patients in Europe since 2021; Nyxoah is now preparing a premarket approval (PMA) supplement submission to the FDA to expand the U.S. indication to this population under Breakthrough Device Designation. Full 12-month data are expected to be presented at the International Surgical Sleep Society annual meeting in Los Angeles, October 15-16, 2026. Read the full release
FemPulse Ring Gains CE Mark Certification for the EU
FemPulse’s Ring, a vaginally-inserted, wireless neuromodulation device for overactive bladder (OAB), has received CE Mark certification under the EU’s Medical Device Regulation and is now listed in the European Database on Medical Devices (EUDAMED). The self-retained ring uses eight programmable surface electrodes to target the nerves controlling communication between the bladder and spinal cord, and is designed to be inserted, worn, and removed by the patient. The certification was supported by safety and efficacy data from four clinical studies. The device remains investigational in the U.S. and is not yet FDA approved or cleared. Read the full release
Low-Frequency Deep Brain Stimulation Improves Speech, Swallowing After TBI
A University of Pittsburgh School of Medicine proof-of-concept study, published in Nature Communications, found that low-frequency deep brain stimulation (DBS) of the motor thalamus improved control of facial and tongue muscles involved in speech and swallowing. Unlike high-frequency DBS (130 Hz), which can suppress speech, the researchers used a lower frequency range of 50-80 Hz. In eight participants with intact speech and swallowing (undergoing DBS for essential tremor), low-frequency stimulation increased activation of face and throat muscles without worsening speech. In one participant with traumatic brain injury (TBI), chronic dysphagia, and severe dysarthria, stimulation improved facial muscle movement, swallowing, and speech control, with word intelligibility improving by 8%, 20%, and 16% across three testing sessions when stimulation was on versus off. The study is not a clinical trial and involved only one TBI participant; the authors say larger studies are needed across more patients and injury types, including stroke. A separate four-week clinical trial (NCT06303869) is now recruiting to test whether DBS produces lasting speech and motor improvements. Read the full paper
Inspire Medical Systems Appoints Michael H. Carrel to BOD
Inspire Medical Systems has appointed Michael H. Carrel to its Board of Directors, effective July 20, 2026. Carrel has served as President and CEO of AtriCure, Inc. since November 2012, during which time the cardiac device company grew from $82 million in revenue in 2013 to $535 million in 2025. He previously served as Chairman of the Board of Axonics, Inc. from 2019 until its acquisition by Boston Scientific in 2024. Carrel holds a B.S. in Accounting from Pennsylvania State University and an M.B.A. from the Wharton School. Read the full release
Axoft Introduces Fleuron WISE
Neurotechnology company Axoft has introduced Fleuron Water Invisible Soft Elastomer (WISE), a UV-curable polymer engineered to match water’s refractive index so it effectively “disappears” when submerged. The material is ultra-soft, flexible, and impermeable to water, reducing optical aberrations for higher-resolution imaging of aqueous biological samples. It is commercially available as a liquid that can be cured into custom shapes or as sheets and can be cast into molds to create micron-scale structures. WISE was developed in collaboration with the Shroff Lab at Janelia Research Campus, which works on visible-light super-resolution imaging inside cells. Axoft uses custom Fleuron formulations in its implantable brain-computer interface devices and also offers Fleuron materials for microfluidics and organ-on-chip systems. The company will present WISE results at the Materials Research Society’s fall meeting in Boston on December 1, 2026. Read the full release
Autonomic, Neural Responses to Transcutaneous Cervical Electrical Stimulation
A pilot study published in Bioelectronic Medicine by researchers including Theodoros P. Zanos examined how transcutaneous cervical electrical stimulation (TCES) parameters affect the autonomic nervous system, using heart rate variability (RMSSD) and EEG alpha-band power as biomarkers of parasympathetic activity. Twenty healthy adults were tested across four frequencies (10, 25, 40, 150 Hz), three current intensities, three electrode montages (bilateral, left-only, right-only), and two durations (4 and 20 minutes). No single frequency produced a significantly stronger response across all participants, but each participant had an individualized “preferred frequency” that produced a mean 41% RMSSD increase in the first visit. Supra-sensation threshold intensity was most effective for 60% of participants, and right-sided or bilateral stimulation increased RMSSD and alpha-band power, while left-sided stimulation decreased both. Because the cardiac vagal response declined across sessions, the preferred frequency had to be recalibrated before duration testing, producing a 54% RMSSD increase upon recalibration (though the preferred frequency shifted for 75% of participants). Longer stimulation duration did not significantly increase autonomic modulation; during 20-minute sessions, peak parasympathetic response emerged around the 4-minute mark. The authors conclude that TCES can modulate cardiac vagal and cortical responses, but that a personalized, biomarker-guided approach to parameter selection is necessary for future clinical use. Read the full paper
