NeuroSigma, Inc.

70 articles about NeuroSigma, Inc.

• NeuroSigma Announces FDA 510(k) Submission for Second Generation Monarch eTNS System

  11/7/2023

  NeuroSigma today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its second-generation Monarch eTNS System™ (Monarch 2.0).

• NeuroSigma Establishes Singapore Subsidiary

  7/12/2023

  NeuroSigma, Inc. announced the launch of NeuroSigma Pte, Ltd., a Singapore corporation, representing NeuroSigma’s first foreign subsidiary.

• NeuroSigma Announces Strategic Digital Marketing Partnership with Data360

  1/31/2023

  NeuroSigma, Inc., a Los Angeles-based bioelectronics company commercializing external trigeminal nerve stimulation (eTNS) technology for treating neurological and neuropsychiatric disorders, today announced the commencement of a strategic digital marketing partnership with Data360, a leading provider of targeted, online marketing for the healthcare industry.

• NeuroSigma Announces that Enrollment Commences in Two Large, Double-Blind Trials of eTNS for Pediatric ADHD

  11/8/2022

  NeuroSigma, Inc., a Los Angeles-based bioelectronics company commercializing external trigeminal nerve stimulation (eTNS) technology for treating neurological and neuropsychiatric disorders, today announced that enrollment has commenced in two large, multicenter double-blind trials of eTNS for pediatric attention-deficit/hyperactivity disorder (ADHD).

• NeuroSigma Announces Commercial Launch of The Monarch eTNS® System for the Treatment of Pediatric ADHD at Annual Meeting of the American Academy of Child and Adolescent Psychiatry

  10/17/2022

  NeuroSigma, Inc. today announced the commercial launch of The Monarch eTNS System at the annual meeting of the American Academy of Child and Adolescent Psychiatry (AACAP) in Toronto.

• NeuroSigma Announces Receipt of Permanent HCPCS Codes from CMS for Monarch eTNS System

  9/27/2022

  NeuroSigma, Inc. announced that the Centers for Medicare & Medicaid Services has confirmed the durable medical equipment benefit category determination and two permanent Level II Healthcare Common Procedure Coding System codes for the Monarch eTNS® System, effective October 1, 2022, as part of the final coding decisions of its biannual update.

• NeuroSigma Announces That a Team Led by UCLA Researchers Receives NIH Grant to Conduct a Multicenter Trial of eTNS for Pediatric ADHD

  6/14/2022

  NeuroSigma, Inc., a bioelectronic medical device company, today announced that a team at the University of California, Los Angeles (UCLA) led by Professor Sandra Loo received a National Institutes of Health (NIH) grant to conduct a double-blind randomized controlled trial of eTNS for pediatric attention-deficit/hyperactivity disorder (ADHD).

• NeuroSigma Announces King’s College London Team Receives MHRA Approval to Commence Largest Clinical Trial of eTNS for Pediatric ADHD to Date

  4/7/2022

  NeuroSigma, Inc., a bioelectronic medical device company, today announced that a team at the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London received approval from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) to commence the largest trial of external Trigeminal Nerve Stimulation (eTNS) ever conducted.

• NeuroSigma Receives FDA Breakthrough Device Designation for Monarch eTNS System®Monarch eTNS Recognized as Novel Device for Drug-Resistant Epilepsy (DRE)

  2/22/2022

  NeuroSigma, Inc., a bioelectronic medical device company, today announced FDA Breakthrough Device Designation for its Monarch eTNS System® for “adjunctive use for reducing the frequency of seizures in individuals 18 years of age or older diagnosed with epilepsy characterized by partial-onset seizures, with or without secondary generalization, that are refractory to two or more antiepileptic medications.”

• Ignis Therapeutics Licenses NeuroSigma eTNS Technology for ADHD in a Significant China Licensing Transaction

  1/26/2022

  NeuroSigma, Inc., a bioelectronic medical device company, and Ignis Therapeutics, a life science company focusing on the central nervous system therapies, jointly announced that Ignis Therapeutics has acquired the exclusive license in China of NeuroSigma’s Monarch eTNS System® to treat attention deficit hyperactivity disorder.

• NeuroSigma Announces Promotion of Dr. Colin Kealey to President

  1/11/2022

  NeuroSigma, Inc., a bioelectronic medical device company, announced the promotion of Dr. Colin Kealey to President.

• NeuroSigma Announces a $5 Million Equity Investment by KT Corporation

  12/8/2021

  NeuroSigma, Inc., a bioelectronic medical device company, announced that KT Corporation has made a $5 million equity investment in NeuroSigma.

• KT and NeuroSigma Announce Strategic Digital Health Partnership

  6/14/2021

  KT Corporation and NeuroSigma, Inc. jointly announced signing of a memorandum of understanding, forming a strategic partnership to develop and commercialize, inside and outside of Korea, electronic therapies treating neurological and neuropsychological disorders, including ADHD, depression, and epilepsy.

• NeuroSigma Continues to Build a Substantial Global Bioelectronics Patent Portfolio

  3/12/2021

  NeuroSigma, Inc., a Los Angeles-based bioelectronics company that is commercializing trigeminal nerve stimulation technology to treat neurological and neuropsychiatric disorders, announced that the following patents have issued or received notices of allowance in Canada and Japan:

• NeuroSigma Successfully Obtains HCPCS Codes from CMS for the Monarch eTNS System

  1/22/2021

  NeuroSigma, Inc., a Los Angeles-based bioelectronics company that is commercializing Trigeminal Nerve Stimulation (TNS) technology for treating neurological and neuropsychiatric disorders, announces that the Centers for Medicare & Medicaid Services ("CMS") is establishing two new Level II Healthcare Common Procedure Coding System ("HCPCS") codes for the Monarch eTNS System®

• NeuroSigma Congratulates Spanish Team for their Results in Randomized Controlled Trial of eTNS in Drug Resistant Epilepsy

  6/24/2020

  NeuroSigma, Inc., a Los Angeles-based bioelectronics company focused on commercializing Trigeminal Nerve Stimulation (TNS) technology for treating neurological and neuropsychiatric disorders today announced that results from a randomized controlled trial of external Trigeminal Nerve Stimulation (eTNS®) for treating drug resistant epilepsy (DRE) were published in the June 2020 issue of the journal Brain Stimulation.

• Teijin and NeuroSigma Enter into Exclusive License Agreement

  10/17/2019

  Teijin Pharma to Market eTNS for the Treatment of ADHD in JaAs part of the agreement, Teijin Pharma will seek regulatory approval in Japan for the Monarch eTNS System (Monarch) for the treatment of ADHD.pan

• NeuroSigma Announces Partnership with Quick Care Pharmacy for Sales and Distribution of the Monarch eTNS System in the US

  10/8/2019

  NeuroSigma, Inc. announced a partnership with Quick Care Pharmacy, a California-based specialty pharmacy, for sales and distribution of its Monarch eTNS System® for the treatment of pediatric ADHD in the United States.

• NeuroSigma Announces Presentation of Clinical Trial Data Showing Increased Brain Activity and Improved Cognition in Children with ADHD Treated with eTNS

  6/27/2019

  NeuroSigma, Inc., announces the presentation of new clinical trial data showing statistically significant changes in brain activity on EEG and improved cognition in children with ADHD treated with external Trigeminal Nerve Stimulation (eTNS®).

• NeuroSigma Announces FDA Clearance of Monarch eTNS System as First Non-Drug Treatment for Pediatric ADHD

  4/24/2019

  NeuroSigma, Inc., a Los Angeles-based bioelectronics company focused on commercializing Trigeminal Nerve Stimulation technology for treating neurological and neuropsychiatric disorders announced that its Monarch® eTNS® System received FDA clearance as a non-drug treatment for attention deficit hyperactivity disorder.