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Soterix Medical Inc. (SMI) was formed to develop and deploy innovative medical treatments focused on neuropsychiatric and neurological disorders and rehabilitation. Founded in 2008, SMI is the world leader in clinical trials for non-invasive neuromodulation working with over 450 medical centers in the US and worldwide. SMI has licensed and developed a comprehensive intellectual property portfolio that includes High-Definition transcranial Direct Current Stimulation (HD-tDCS), Limited Total Energy tDCS (LTE-tDCS), and Neurotargeting. From the most targeted non-invasive clinical systems to the most portable units, Soterix Medical provides clinicians and patients with unique and adaptable solutions. Ongoing Phase I, II, IIb, and III trials use investigational devices that are regulated/limited by US or Federal law. SMI is proudly based in the Tri-state area with international distributors in all major markets.
At Soterix Medical, Engineering Serving Humanity means that we are committed to bring the most advanced medical technology into the hands of people who need it. The commitment underpins everything we do.
1480 U.S. 9N,WOODBRIDGE, NJ 07095
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Researchers and clinicians choose Soterix Medical devices and accessories where the highest standards in performance are required. Soterix Medical products stand-out for their usability, unique features, and precision. Leveraging the most advanced scientific understanding, Soterix Medical technology is the forefront of neuromodulation clinical trials for the treatment of neuropsychiatric disorders and rehabilitation.
The industry standard with the first devices and accessories designed for low-intensity non-invasive electrical brain modulation.
1x1 tDCS: transcranial Direct Current Stimulation
1x1 tDCS-LTE: tDCS with Limited Total Energy
1x1 tACS: transcranial Alternating Current Stimulation
1x1 tES: transcranial Electrical Stimulation
1x1 CT: tES/tDCS for Clinical Trials
Optimization of electrode montage for cortical and subcortical targeting and individual subject customization.
The most advanced non-invasive neuromodulation platform, presenting High-Definition tDCS. Exclusively from Soterix.
Deployed transcranial electrical stimulation, without compromise.
Combine tDCS with monitoring technologies. Including EEG, PET, MEG, eye-tracking, NIR, fMRI and more.
The first and only device and accessories optimized for non-invasive galvanic electrical stimulation.
The only system, electrodes, and accessories designed for controlled tsDCS.
The most advanced TMS with unmatched strength and control.
The most precise, reliable, and consistent image-guided navigation.
The highest density fNIRS system in an ergonomic form factor.
The only Animal DCS system and integrated accessory set optimized for pre-clinical research on tDCS.
The first truly mobile EEG device offering research-grade brain signals
The only integrated device and accessory set for clinical research on interferential (IF) or temporal interference (TI) stimulation
Soterix Medical Inc. announces it has received FDA Investigational Device Exception (IDE) to launch a trial of transcranial Direct Current Stimulation-Limited Total Energy (tDCS-LTE) neuromodulation at-home for patients with Major Depressive Disorder (MDD).
Learn more about tDCS-LTE
Soterix Medical Inc. he global leader in non-invasive stimulation and synergistic technologies, announced today it has received a 510(k) clearance from U.S. Food & Drug Administration (FDA) for the Neural Navigator system manufactured by Brain Science Tools, Netherlands.
Learn more about the Neural Navigator System
Soterix Medical Inc. announced the launch of its U.S. Food and Drug Administration (FDA) 510k cleared electro-detox™ treatment to reduce opiate and opioid withdrawal symptoms. The electro-detox™ is a battery-powered wearable device placed behind the patient’s ear that emits gentle current pulses to stimulate branches of specific cranial nerves
Learn more about Electro-Detox treatment
Soterix Medical Inc. has been awarded a Phase I NIH-SBIR contract from the National Institute of Drug Abuse (NIDA) of the National Institutes of Health (NIH) for the development of its portable remote-tDCS platform for the treatment of cocaine addiction.
The focus of the project is to develop and validate the first self-administered electrostimulation system to reduce cocaine craving. The stimulation device and protocols developed in this project are further applicable to other addictive substances like nicotine, alcohol, and marijuana and to opioid misuse.
Learn more about Self-Administered Neuromodulation
Soterix Medical Inc. reported positive results from two double-blind, sham-controlled clinical trials of its proprietary transcranial Direct Current Stimulation-Limited Total Energy (tDCS-LTE) technology for the treatment of depression. The Depression tDCS-LTE system is unique in providing drug-free therapy with minimal side effects while maximizing energy delivery to the dorsolateral prefrontal cortex (DLPFC) region, which is implicated in depression control.
The results of the first study “Bipolar Depression Electrical Treatment Trial [BETTER]” were published in JAMA Psychiatry and the results of the second study “ELECT-tDCS” trial were published in New England Journal of Medicine.
Access the First Study
Access the Second Study
Learn more about Depression tDCS-LTE System
Soterix Medical Inc. announced that it has received Singapore’s Health Sciences Authority (HSA) approval for its non-invasive therapeutic medical device. This approval allows Soterix Medical to immediately market its products based on its proprietary transcranial Direct Current Stimulation (tDCS) technology in Singapore. The therapy works by delivering a mild electrical current through electrodes placed on the head relieving the symptom of Major Depression using the Depression tDCS-LTE™ treatment or Fibromyalgia using the PainX™ treatment.
Learn more about Depression tDCS-LTE System
Learn more about PainX System
Soterix Medical Inc. announced it has received a 510(k) clearance from U.S. Food & Drug Administration (FDA) for its IontoDC™ device intended to use a direct current to introduce ions of soluble salts or other drugs into the body.
When the Smithsonian highlighted the most rigorous science around tDCS, they showed Soterix Medical’s exclusive High-Definition tDCS system. Targeted stimulation supporting hypothesis driven research.
Learn about High-Definiton tDCS
Learn about Neurotargeting Software
Al Jazeera America features clinical grade tDCS using industry-standard Soterix Medical technology in adult and pediatric neurorehabilitation*. And an interview with our CTO, Dr. Abhishek Datta.
Industry Standard 1x1 tDCS
For Susceptible Populations 1x1 tDCS-LTE
The Soterix Medical PainX™ tDCS system receives CE Mark for the treatment of Pain including Migraine and Fibromyalgia. Soterix Medical tDCS systems continue to set the standard in research and treatment.
Learn more about PainX™ treatment
The Soterix Medical 1x1 tDCS system receives CE Mark for the treatment of Depression. Medical and research quality tDCS from the trusted leader in transcranial electrical neuromodulation.
Learn about tDCS-LTE Therapy for Depression
Soterix Medical tDCS features on PBS inducing the industry standard 1x1 (start of episode) and our 1x1-LTE, the only device designed for susceptible population (end of episode)
More on Soterix Medical tDCS and LTE™
Motherboard’s lighthearted take on Soterix Medical's exclusive HD-tDCS technology. Learn more about Soterix Medical HD-tDCS for state-of-the-art research and clinical grade neuromodulation.
More on 4x1 HD-tDCS
Brain Targeting Software
Soterix Medical EASYstrap features in Scientific American Mind article on “Your Electric Pharmacy”, the future of tDCS
More on EASYstrap™
Learn more about Home Neuromodulation.
Our exclusive "X configuration" overcomes limitations of conventional tDCS. Soterix HD-tDCS can "penetrate deeper into the brain in more focused areas", reports Nature News.
More on HD-tDCS
Soterix Medical Inc. partners with ElMindA Ltd. to develop a new paradigm for pain control. Visualizing individual pain networks to revolutionalize the targeted treatment of pain - one patient at a time.
Harvard medical school trial
For combining tDCS with monitoring technologies (such as EEG, PET, MEG, Eye-tracking, NIR, fMRI) - Soterix Medical is the only company with the technology and expertise to ensure successful integration.
Contact SMI technical support
WIRED magazine features Soterix medical tDCS and HD-tDCS products in their feature on neuromodulation including our exclusive 4x1 montage for brain targeting”.
Learn more on tDCS
Get started with HD-tDCS
Soterix High-Definition tDCS an "innovation" that "increases the functional resolution" of brain stimulation. Categorical increases in non-invasive targeting with simple to use technology.
Soterix Medical Neurotargeting
Physicians at Harvard Medical School demonstrate the application of tDCS for clinical trial on patients using a Soterix 1x1 device in this Journal of Visualized Experiments video.
Watch the JOVE video
Explore tDCS Devices & Accessories
Soterix EASY-Kits include everything you need for a complete tDCS session in a compact container. Compatible with all Soterix 1x1 Stimulators and Accessories and includes Soterix EASY-Pads.
Learn more about tDCS Accessories
The CT-tDCS platform is the most sophisticated system for clinical trials with tDCS and the only system to provide true double-blind control and online subject monitoring.
Learn more about CT tDCS
The study team is investigating whether or not transcutaneous auricular vagus nerve stimulation (taVNS) can treat neurologic symptoms of COVID-19 which are termed NEUROCOVID.
Access complete clinical trial information here
More on Soterix Medical taVNS platforms
The purpose of this study is to assess the feasibility, acceptability, and efficacy of self-administered transcranial direct current stimulation (tDCS) in older adults with knee osteoarthritis (OA)
More on Soterix Medical Remote tDCS Platforms
This study will evaluate the feasibility and efficacy of home-administered transcranial Direct Current Stimulation (tDCS) treatment for depression.
FDA IDE trial of transcranial Direct Current Stimulation-Limited Total Energy (tDCS-LTE) neuromodulation at-home for patients with Major Depressive Disorder (MDD).
This study will investigate the effects of transcutaneous direct current stimulation (tsDCS) on walking function in individuals with incomplete spinal cord injury.
More on Soterix Medical tSDCS System
Pragmatic clinical trial that aims to determine the effect of tDCS on symptomatic fatigue in Multiple Sclerosis (MS) patients. This is a randomized, blinded, sham-controlled study design to determine the effect of Transcranial Direct Current Stimulation (tDCS) on MS participants to reduce feelings of fatigue.
More on Soterix Medical 1x1 mini-CT
Due to the limited effectiveness of conventional speech therapy strategies in post-stroke aphasia an effective novel treatment is therefore needed to improve recovery in these patients.
A double-blind randomized controlled design will be conducted. Participants will randomly be assigned either to the tDCS group or to the sham (placebo) group.
More on Soterix Medical transcranial Direct Current Stimulator Clinical Trials (1x1-CT) system
Study aims to understand and determine how tDCS works, how it can be optimized, and if it can be used as an effective intervention for reducing depressive symptoms in people suffering from Major Depression
More on Soterix Medical MxN line of stimulators
The study aims to assess the change in EEG alpha brain waves in women with CPP after guided imagery sessions with tDCS actual or sham treatments. The study also aims to assess the change in pain, urinary symptoms, and quality of life in women after guided imagery sessions with tDCS actual or sham sessions.
More on Soterix 1x1 tDCS Devices
Trial will assess the individual and combined impact of pairing cognitive training with tDCS in adults (65-89 years).
Soterix Medical 1x1 Clinical Trials (CT) device using Limited Total Energy (LTE™) technology is being used in the study.
More on Soterix Medical More on Soterix Medical 1x1 CT stimulator
This study evaluates the application of non-invasive brain stimulation in the treatment of Mild Cognitive Impairment (MCI) in adults aged 55-85.
Soterix Medical 1x1 tES device is being used in the study.
More on Soterix Medical More on Soterix Medical 1x1 tES stimulator
This study explores the effects transcranial Direct Current Stimulation on Phantom Limb Pain for patients experiencing chronic phantom limb pain in open-label study design.
Soterix Medical 1x1 tDCS device is being used in the study.
More on Soterix Medical 1x1 tDCS stimulator
The purpose of the pilot study will be to evaluate the feasibility of open label Transcranial direct current stimulation (tDCS) in combination with computerized cognitive behavior therapy (cCBT) to maintain wellness following an acute course of Electroconvulsive therapy (ECT) for up to 6 months.
Soterix Medical 1x1 tDCS mini-CT device is being used in the study
More on Soterix Medical 1x1 CT stimulator
The proposed study seeks to obtain preliminary signal of the tolerability and efficacy of transcranial direct current stimulation (tDCS) for depressive symptoms in a sample of adolescents with depression and epilepsy.
Soterix Medical 1x1 tDCS device is being used in the study
Soterix Medical 1x1 Clinical Trials device with Limited Total Energy (LTE) to be used in a trial to study the antidepressant effects of tDCS in bipolar disorder.
Enrollment information at NIH ClinicalTrials.Gov
More on Soterix Medical LTE™ and CT
Hunter College of The City University of New York will investigate the use of Soterix Medical 1x1 tDCS (transcranial direct current stimulation) in conjunction with speech-language therapy, for the improvement of language production in stroke survivors with aphasia.
More on Hunter College.
Trial will compare Soterix Medical tDCS-LTE™ technology against a fully dosed, effective antidepressant Escitalopram oxalate (Lexapro). Recruitment ongoing.Soterix Medical 1×1 Clinical Trials (CT) device using Limited Total Energy (LTE™) technology is being used in the study.
Trial will assess the clinical and neurophysiological effects of a non-invasive brain stimulation technique - transcranial direct current stimulation (tDCS)- on cortical plasticity and motor learning in children with cerebral palsy.
More on Soterix Medical 1×1 stimulator
This study will evaluate the influence of non-invasive brain stimulation on different elements of cognitive function in healthy persons between the ages of 18-90 years. Soterix Medical 1×1 tDCS device is being used in this study.
Spaulding Rehabilitation Hospital and the US Department of Education will investigate the effects of Soterix Medical 1x1 transcranial direct current stimulation (tDCS) on the pain and itching associated with burn injury. This study is part of the Boston-Harvard Burn Model System.
More on the Boston-Harvard Burn Injury Model System
Follow up Phase II, HD-tDCS clinical trial underway for fibromyalgia at Harvard Medical School and Spaulding Rehabilitation Hospital, and in conjunction with Elminda Corporation. Exclusive Soterix 4x1 HD-tDCS being used.
More information on the Spaulding Neuromodulation Lab
This study is testing whether the addition Soterix Medical 1x1 transcranial direct current stimulation (tDCS) when combined with meditation helps decrease the abdominal pain in patients with chronic pancreatitis.
More on Soterix Medical 1×1 Devices.
Study focused on investigating effect of tDCS on chronic corneal pain as well as changes in thought processing as compared to healthy controls. Soterix 1×1 Device is being used.
Boston Foundation of Sight
Study focused on evaluating the effect of a combination of robotic arm therapy and transcranial Direct Current Stimulation for greater functional recovery after stroke.
North Shore Long Island Jewish Health System
For the most comprehensive tDCS trial to-date, researchers selected the most advanced tDCS device and the only system optimized for clinical trials – The Soterix Medical 1x1-CT.
Clinical Trials tDCS Devices by Soterix
Epilepsy Foundation awards a New Therapy Grant for a clinical trial of High-Definition tDCS in pediatric epilepsy. Dr. Alexander Rotenberg will lead a team of clinical investigators including at BCH and Harvard Medical School.
NIH grants Burke Medical Research Institute $3m to conduct the most controlled trial of tDCS for stroke rehabilitation to date. The Soterix Medical 1x1 platform is the most advanced and the industry standard for tDCS clinical trials for rehabilitation.
More Details at NIH
tDCS lab at Burke Rehab.
Soterix Medical Inc. receives FDA Clinical Trial IDE for High-Definition tDCS (HD-tDCS) to improve IQ in pediatric Down syndrome. HD-tDCS is the only non-invasive, brain targeted, and low-intensity technology designed to promote neuroplasticity.
Soterix Medical INC. HD-tDCS
Soterix Medical INC. Limited Total Energy (LTE™) for Susceptible Populations
More Info. at NIH
Dr. Bernadette Gillick's Pediatric Rehabilitation Laboratory is supported by the NIH and University of Minnesota Clinical and Translational Science Institute to investigate the use of a form of tDCS for interventions in rehabilitation for children. Subject specific analysis with Soterix Medical Neurotargeting™ will guide current to brain cells in the injured part of the brain.
More info at Uni. of Minnesota.
More Information of Clinical trials
HD-tDCS clinical trial underway for fibromyalgia at Harvard Medical School and Spaulding Rehabilitation Hospital, Boston.
More info at Massachusetts CFIDS/ME & FM Association
NIH grants Soterix a Phase-1 STTR grant to develop HD-tDCS for stroke rehabilitation. The first technology capable of delivering therapeutic direct current to target brain regions involved in functional recovery.
Clinical trials at The Aphasia Lab at The University of South Carolina