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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets
The Directory // Neurology & Neurotech

Neurology & Neurotech

Neuromodulation, brain-computer interfaces, stroke and neurodiagnostics. 71 companies listed.

Boston, MA  ·  Est. 2017  ·  Unknown  ·  Submission pending

Developing a non invasive brain stimulation device patients can use at home, in FDA pivotal trials for major depressive disorder with pilot work in Alzheimer's and Parkinson's disease.

Worcester, MA  ·  Series A  ·  $11.3M raised  ·  In development

Builds an MRI-compatible surgical robot that lets neurosurgeons place leads, take biopsies and ablate tumors while the patient is inside the scanner. It won a $2 million Phase II SBIR from the National Cancer Institute in September 2026.

London, UK  ·  Est. 2020  ·  Series A  ·  $100M raised  ·  Submission pending

Developing Amber-UI, an adaptive neuromodulation implant that senses as well as stimulates, for mixed urinary incontinence in women. Spun out of Oxford University research.

Marin, CA  ·  Est. 2015  ·  Unknown  ·  Submission pending

Builds funnel catheters used alongside stent retrievers during thrombectomy for large vessel occlusion stroke. Its ANA Funnel Catheter is in the 327-subject ATHENA IDE trial in the US.

Hanover, NH  ·  Est. 2016  ·  Unknown  ·  510(k) cleared

Makes Neurora, software that scores video and audio from a standard pediatric behavioral assessment to aid autism spectrum disorder diagnosis in children 18 months through 12 years.

Unknown  ·  In development

Builds NeoCast, a liquid embolic for chronic subdural hematoma, and ResQFoam for hemorrhage control. Terumo Neuro agreed in September 2026 to acquire the company.

St. Louis, MO  ·  Est. 2024  ·  Seed  ·  Breakthrough designation

Washington University spinout developing V-Link, a noninvasive ear-worn vagus nerve stimulator to reduce cerebral vasospasm after aneurysmal subarachnoid hemorrhage. Breakthrough Device designation granted June 30, 2026.

San Francisco, CA  ·  Est. 2020  ·  Unknown

Developing a neurostimulation implant for hearing loss in patients who no longer benefit from hearing aids but are not candidates for cochlear implants. Came out of Stanford Biodesign.

The Woodlands, TX  ·  Est. 2014  ·  Public

A catheter with a microchip sensing array that detects individual nerve signals from inside a blood vessel, ablates the overactive ones and checks the result during the procedure. First clinical work is in pancreatic cancer pain.

Cambridge, MA  ·  Est. 2021  ·  Series A  ·  $60M+ raised

Develops implantable brain-computer interfaces made from Fleuron, a soft polymer intended to reduce scarring and signal drift. In early human trials; no FDA marketing authorization yet.

Boston, MA  ·  Series B  ·  $132M+ raised  ·  510(k) cleared

Beacon Biosignals makes the Waveband EEG headband and AI sleep-staging software, and sells brain-function biomarkers to drug developers.

Atlanta, GA  ·  Unknown  ·  510(k) cleared

Makes NerveTape, a sutureless device that joins two cut nerve ends with microhooks embedded in porcine submucosa. Axogen agreed to buy the company for $200 million in cash in September 2026.

Richmond, VA  ·  Unknown  ·  Submission pending

Traumatic brain injury test that combines blood biomarkers with digital neurocognitive testing into a single composite score, built to run at the point of care.

Seattle, WA  ·  Est. 2021  ·  Unknown  ·  510(k) cleared

Makes Intellidrop, an automated external CSF drainage system that measures intracranial pressure continuously and drains to a set pressure or volume target in the ICU.

Seed  ·  $13.5M raised  ·  In development

Developing a non-invasive brain-computer interface that reads neural activity through the skull with functional ultrasound. Licenses Butterfly Network's ultrasound-on-a-chip platform. Spun out of Forest Neurotech.

Boston, MA  ·  Est. 2014  ·  Series C  ·  Breakthrough designation

Developing eShunt, an endovascular cerebrospinal fluid shunt for normal pressure hydrocephalus placed through femoral venous access. Breakthrough-designated and in the STRIDE trial ahead of a PMA.

Cork, Ireland  ·  Est. 2021  ·  Unknown  ·  Over 11 million euros raised  ·  Breakthrough designation

Builds Wave, software that reads newborn EEG for signs of brain injury without a specialist to interpret the trace. Spun out of University College Cork's INFANT Research Centre.

Sunnyvale, CA  ·  Est. 2014  ·  Public  ·  510(k) cleared

Point-of-care EEG for acute care. A disposable headband and portable recorder pair with seizure detection and quantitative trending software so bedside staff can start a study without a technologist.

New York, NY  ·  Est. 2012  ·  Series D+  ·  510(k) cleared

Develops prescription software treatments for psychiatric and neurological conditions. Its cleared product, Motivista, treats the negative symptoms of schizophrenia as an adjunct to antipsychotic therapy.

Cambridge, MA  ·  Est. 2016  ·  Series C  ·  Breakthrough designation

Builds Spectris, a prescription home-use device that delivers gamma frequency light and sound stimulation for Alzheimer's disease. The device holds Breakthrough Device designation and is in the HOPE trial ahead of an FDA submission.

Seed  ·  $10M raised  ·  In development

Building SOMA-1, a coin-sized wireless implant that monitors electrical activity and delivers targeted stimulation as part of cancer treatment.

London, UK  ·  Series A  ·  $102.5M raised  ·  Submission pending

CoMind is developing CoMind One, a non-invasive optical monitor for cerebral blood flow, autoregulation and intracranial pressure in critical care.

Mountain View, CA  ·  Seed  ·  Breakthrough designation

Cordance Medical is developing a focused ultrasound system that temporarily opens the blood-brain barrier for drug delivery and liquid biopsy in brain tumors.

Freiburg, Germany  ·  Est. 2010  ·  Unknown  ·  Breakthrough designation

Builds Brain Interchange, a fully implantable wireless brain-computer interface that records cortical activity and delivers stimulation in a closed loop. In FDA-authorized clinical evaluation for motor rehabilitation after stroke.

Baltimore, MD  ·  Est. 2021  ·  Series B  ·  510(k) cleared

Makes patient-specific cranial implants and is developing NeuroPASS, a skull-embedded platform for brain access, sensing and drug delivery.

Salt Lake City, UT  ·  Series B  ·  $46M raised  ·  510(k) cleared

Makes REMI, a wireless wearable EEG system with disposable sensors that records brain activity for up to 30 days in hospitals and at home, with AI event detection for clinician review.

Malmö, Sweden  ·  Est. 2016  ·  Series A  ·  PMA approved

Flow Neuroscience makes a home-use tDCS headset paired with a behavioral therapy app for depression. It has sold in the UK and Europe since 2019.

Chengdu, China  ·  Est. 2025  ·  Seed  ·  Not a regulated device

Works on ultrasound based brain computer interfaces, neuromodulation and functional ultrasound imaging, all without an implant. Registered in September 2025 and announced its launch in January 2026.

Tempe, AZ  ·  Est. 2017  ·  Series D+  ·  $214M raised  ·  510(k) cleared

Sells GammaTile, a bioresorbable brachytherapy implant placed in the resection cavity during brain tumor surgery. Cleared under 510(k) with product code KXK and used at more than 150 US cancer centers.

South Korea  ·  Est. 2022  ·  Series A  ·  KRW 33.5B raised

Hurotics builds H-Medi, a cable-driven soft exosuit for gait rehabilitation, and H-Care, a walking assist device for everyday use.

Barcelona, Spain  ·  Series B  ·  $50M raised  ·  Breakthrough designation

Spun out of Barcelona's ICN2 to build graphene cortical interfaces about 10 micrometers thick, aimed first at Parkinson's disease. Ran the first human procedure with a graphene brain interface in September 2024.

Dallas, TX  ·  Unknown  ·  510(k) cleared

Makes the CLEAR aspiration platform, a pump and single-use catheter system that uses cyclical aspiration to remove clots. Cleared in the US for peripheral vessels and CE marked in the EU.

Paris, France  ·  Seed  ·  3 million euros raised  ·  In development

Mechanical thrombectomy for acute ischemic stroke, aimed at clot removal and revascularization. Still preclinical.

Series A  ·  $18M raised  ·  In development

MIT spinout building magnetically steerable guidewires with robotic control and navigation software for stroke thrombectomy.

Est. 2026  ·  Seed  ·  $252M raised  ·  In development

Brain-computer interface startup co-founded by Sam Altman, Alex Blania, Sandro Herbig and researchers Tyson Aflalo, Sumner Norman and Mikhail Shapiro. It is developing less invasive neural interfaces built on ultrasound and molecular approaches instead of implanted electrodes. It raised a $252M seed round in January 2026 and licensed Butterfly Network's ultrasound-on-chip technology in September 2026.

Brooklyn, NY  ·  Unknown  ·  510(k) cleared

Software that denoises and sharpens MRI and PET images using random matrix theory and MR-guided reconstruction. A spinout of NYU Langone Health.

London, UK  ·  Est. 2022  ·  Seed  ·  In development

Designs application-specific semiconductor chips for neural sensing, signal processing and stimulation, sold to companies building implants, brain-computer interfaces and sensory prostheses.

Austin, TX  ·  Est. 2007  ·  Public  ·  PMA approved

Formerly MicroTransponder. Sells the Vivistim Paired VNS System, an implanted vagus nerve stimulator approved under PMA P210007 for upper limb rehabilitation after chronic ischemic stroke. Listed on Nasdaq as MOBI in May 2026.

Houston, TX  ·  Series A  ·  $18.75M raised  ·  Submission pending

Developing DOT, a battery-free neurostimulator smaller than a centimeter that sits in a burr hole in the skull and draws wireless power from a wearable headset, for treatment-resistant depression.

Paris, France  ·  Seed  ·  510(k) cleared

Builds an earbud-based EEG system that records single-channel brain activity at home and sends it to clinicians. Cleared in the US in January 2026.

Los Angeles, CA  ·  Series B  ·  $65.5M raised  ·  In development

Develops an implantable peripheral nerve stimulation system for chronic pain, using a miniaturized pulse generator and leads controlled from a wearable programmer and mobile app.

Los Angeles, CA  ·  Seed  ·  510(k) cleared

Makes STEDI, a portable bioimpedance spectroscopy device that measures fluid distribution in the head to help assess cerebral fluid volume asymmetry between hemispheres at the bedside.

Cork, Ireland  ·  Est. 2024  ·  Seed  ·  2.1 million euros raised  ·  Submission pending

Builds a pocket-sized wireless brain monitor that detects seizures in newborns at the NICU bedside. Spun out of University College Cork in January 2024.

Baar, Switzerland  ·  Est. 2014  ·  Series A

NeuroGyn develops PosStim, a pelvic neuromodulation platform aimed first at overactive bladder.

Netanya, Israel  ·  Unknown  ·  PMA approved

Neurolief makes wearable multi-channel neuromodulation headsets for home use, including Relivion MG for migraine and ProlivRx for depression. It has offices in Netanya, Israel and Coral Springs, Florida.

Eden Prairie, MN  ·  Public  ·  510(k) cleared

Makes thin-film electrode and radiofrequency ablation systems for the brain and nerves, including the Evo cortical and sEEG electrodes and the OneRF ablation systems.

Los Angeles, CA  ·  Unknown  ·  510(k) cleared

Makes the Monarch eTNS System, an external trigeminal nerve stimulation device worn at night. FDA cleared it as the first non-drug treatment for pediatric ADHD, and cleared a second-generation version in January 2024.

Dallas, TX  ·  Unknown  ·  Submission pending

Builds the ReWire closed-loop vagus nerve stimulation system, a wireless implant with no battery that pairs stimulation with limb movements during stroke rehabilitation.

Pleasanton, CA  ·  Acquired  ·  De Novo granted

Makes Nidra, a pair of wearable units that stimulate the peroneal nerves to reduce symptoms of moderate to severe restless legs syndrome in adults whose medication has stopped working. Resmed acquired the company in June 2026.

Sydney, Australia  ·  Est. 2019  ·  Series B  ·  510(k) cleared

Builds Quicktome, software that turns MRI and resting state functional MRI into patient specific maps of brain networks for surgical planning and deep brain stimulation.

Austin, TX  ·  Unknown  ·  Breakthrough designation

Builds Connexus, a fully implanted intracortical brain-computer interface that records single-neuron activity across hundreds of channels and sends it wirelessly through intact skin.

Galway, Ireland  ·  Series A  ·  €44.5M raised  ·  510(k) cleared

Makes aspiration and access catheters for mechanical thrombectomy in ischemic stroke, including the 0.088-inch Millipede88.

Maple Grove, MN  ·  Unknown  ·  510(k) cleared

Makes linerless neurointerventional access catheters, including the NeuGlide and NeuFlex lines, for introducing devices into neuro, coronary and peripheral vasculature.

New York, NY  ·  Est. 2021  ·  Series D+  ·  $430M raised  ·  510(k) cleared

Builds the Layer 7 Cortical Interface, a thin-film electrode array that rests on the surface of the brain instead of penetrating it, so people with paralysis can control digital devices. Owns a MEMS fab in Texas that makes the arrays.

Miami, FL  ·  Series B  ·  $58.5M raised  ·  In development

Builds a cyclic aspiration system for mechanical thrombectomy in acute ischemic stroke, running the TURBO IDE study toward a US submission.

Norwich, VT  ·  Est. 2025  ·  Series A  ·  Not a regulated device

Wireless power transfer platforms for implantable devices, spun out of Resonant Link in November 2025. Its Aurion platform targets neuromodulation, cardiac rhythm management and brain-computer interfaces.

West Jordan, UT  ·  Growth  ·  510(k) cleared

Builds neurovascular access and aspiration catheters for ischemic stroke, including the FreeClimb and HiPoint reperfusion systems and the Tenzing delivery catheter.

Eindhoven, Netherlands  ·  Est. 2017  ·  Series B  ·  Submission pending

Builds an implanted neuromodulation system for migraine. Two ultra thin implants sit just beneath the skin, one at the front of the head and one at the back, and a wearable activates therapy twice daily.

Est. 2021  ·  Series C  ·  $490M raised  ·  Submission pending

Develops the PRIMA retinal implant, a photovoltaic chip that acts as artificial photoreceptors to restore central vision lost to geographic atrophy.

Lake Forest, CA  ·  Unknown  ·  Breakthrough designation

Clinical-stage neurovascular company developing BosSTENT, a braided self-expanding stent for cerebral venous sinus stenosis, and the BosCATH support catheter used to deliver it.

Irvine, CA  ·  Series A  ·  Submission pending

Spiro Medical is developing an implantable spinal nerve stimulator to reduce symptoms in severe, uncontrolled asthma.

New York, NY  ·  Series D+  ·  $345M raised  ·  Submission pending

Synchron builds the Stentrode, an endovascular brain-computer interface implanted through the blood vessels so people with paralysis can control digital devices.

Boston, MA  ·  Est. 2018  ·  Unknown

Developing implantable closed loop neuromodulation devices that sense and stimulate brain activity, aimed at improving deep brain stimulation for Parkinson's disease, essential tremor and epilepsy.

Cambridge, UK  ·  Est. 2017  ·  Seed  ·  CE mark

Builds rapid point-of-care blood tests for time-critical conditions. Its LVOne test measures GFAP and D-dimer to identify large vessel occlusion stroke in about 10 minutes, for use by paramedics before a patient reaches hospital.

Kitchener, ON, Canada  ·  Est. 2016  ·  Unknown  ·  510(k) cleared

Builds a miniature forward-looking camera for neurovascular and peripheral procedures, plus the Balloon Distal Access Catheter for stroke thrombectomy.

Miami, FL  ·  Unknown  ·  510(k) cleared

Builds SmartVertigo, a portable vestibular assessment system that records and classifies nystagmus during positional testing using a smartphone and a light-blocking headset.

San Francisco, CA  ·  Est. 2018  ·  Acquired

Developed a device that cools the brain to limit damage during a stroke. Acquired by Penumbra.

San Jose, CA  ·  Unknown  ·  Breakthrough designation

Developing a self-expanding stent and delivery system for venous sinus stenosis, aimed at pulsatile tinnitus. Founded by UCSF neurointerventional radiologist Matthew Amans.

Paris, France  ·  Est. 2012  ·  Series D+  ·  510(k) cleared

Builds self-balancing walking exoskeletons for rehabilitation clinics and for personal use by people with spinal cord injury.

San Francisco, CA  ·  Est. 2019  ·  Unknown

Makes a wearable headband that uses EEG sensors and machine learning to detect a stroke as it starts and alert emergency services.

Boston, MA  ·  Est. 2018  ·  Unknown  ·  510(k) cleared

Sells a navigation and robotics platform that uses computer vision for image guidance in minimally invasive procedures. The Zeta Navigation System and Zeta TMS Navigation System are FDA cleared.

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