Soterix Medical Inc. the global leader in stimulation and synergistic monitoring technologies, announced today it has received a 510(k) clearance from the U.S. Food & Drug Administration for its Intraoperative Neurophysiologic Monitoring (IOM) system, MEGA-IOM. The system provides unmatched integrated control of central and peripheral nervous systems to reduce postoperative risk and improve surgical outcomes.

Soterix Medical Inc. the global leader in non-invasive brain stimulation and synergistic monitoring technologies, announced the launch of MxN-GO EEG, a combined High Definition transcranial Electrical Stimulation (HD-tES) and EEG system with a unique untethered design. The system is intended for research applications requiring electrical stimulation and recording of brain activity in mobile and natural environments.

Soterix Medical Inc. announces the launch of a Phase-2 clinical trial that will evaluate the combination of REMOTE-tDCS and a brain training program for the treatment of long COVID. The trial will be administered through NYU Langone Health's home-based remotely supervised (RS) tDCS program, which includes a clinical service that is available to patients across the United States.

Soterix Medical Inc. the global leader in non-invasive stimulation and synergistic brain imaging technologies, announces a new clinical trial of home-based auricular Vagus Nerve Stimulation (taVNS) for individuals who experience post-COVID neuropsychiatric symptoms, like fatigue, headache, or anxiety.

Soterix Medical Inc. the global leader in non-invasive stimulation and synergistic brain imaging technologies, is pleased to report expanded clinical trials of its proprietary neuromodulation technologies for Alzheimer's disease and Mild Cognitive Impairment.

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.