ElectroCore wins cluster headache FDA 510(k) indication for GammaCore

ElectroCore said today that it won expanded FDA 510(k) clearance for its GammaCore non-invasive vagus nerve stimulation therapy, now cleared for adjunctive use for the preventive treatment of cluster headaches in adult patients. The Basking Ridge, N.J.-based company’s GammaCore device is a non-invasive, hand-held vagus nerve stimulation device designed for the reduction of pain. The system is intended to be applied to the neck and applies a patented electrical stimulation through the skin to activate the vagus nerve. The expanded approval was supported by results from two studies which demonstrated the safety and efficacy of the system in preventing the treatment of cluster headaches, ElectroCore said, including data from its pivotal Preva study and a real-world retrospective study. Results from the Preva study indicated that patients who received the standard of care and treatment and treatment with the GammaCore had a greater reduction in the number of cluster attacks per week from baseline than those who only received the standard of care. Patients treated with the GammaCore device experienced a total of 3.9 fewer attacks per week, ElectroCore said. Data also indicated that 40% of patients who received GammaCore treatment alongside the standard of care had a 50% or greater reduction in weekly cluster attacks, versus only 8.3% of patients who received the standard of care, ElectroCore said. Investigators also noted a 57% decrease in the frequency of abortive medi...
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Featured Food & Drug Administration (FDA) Neurological Regulatory/Compliance electroCore Source Type: news

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Authors: Patel P, Konala VM, Adapa S, Gayam V, Sahasranam P, Bose S, Golez CD, Naramala S Abstract Cyanide is notoriously known to the public for more than a century now as a weapon of mass destruction (Zyklon B gas - hydrogen cyanide used by Nazis), an agent for chemical warfare during World War I (hydrogen cyanide) and very infamous "Suicide Pill" used in the past by military and espionage organizations during World War II (potassium cyanide). During the modern industrial era, cyanide poisoning is commonly associated with the industrial exposure and domestic fires. But there is little awareness about po...
Source: Journal of Population Therapeutics and Clinical Pharmacology - Category: Drugs & Pharmacology Tags: J Popul Ther Clin Pharmacol Source Type: research
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Source: Psychiatr News - Category: Psychiatry Tags: Journal of the American Academy of Adolescent Psychiatry medications for youth with anxiety and OCD selective serotonin reuptake inhibitor side effects SNRIs treatment discontinuation Source Type: research
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Source: World of Psychology - Category: Psychiatry & Psychology Authors: Tags: Antidepressant Antipsychotic General Medications Mental Health and Wellness Not Crazy Podcast Psychology Research Sexuality Stimulants Treatment Source Type: blogs
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Source: Social Psychiatry and Psychiatric Epidemiology - Category: Psychiatry Source Type: research
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Source: Frontiers in Psychiatry - Category: Psychiatry Source Type: research
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Source: Frontiers in Psychiatry - Category: Psychiatry Source Type: research
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Source: PediatricEducation.org - Category: Pediatrics Authors: Tags: Uncategorized Source Type: news
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Source: MedicineNet Migraine General - Category: Neurology Source Type: news
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Source: the Mail online | Health - Category: Consumer Health News Source Type: news
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