Soterix Medical is the world leader in non-invasive neuromodulation and integrated brain monitoring technology
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.
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).
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.