ElectroCore Seeks EUA for Vagus Nerve Stimulation Therapy
ElectroCore announced it has filed for FDA’s Emergency Use Authorization for its GammaCore Sapphire vagus nerve stimulation therapy for treating COVID-19 respiratory symptoms.
The handheld, non-invasive therapy is placed on a patient’s neck and can be self-administered. Early clinical and non-clinical data included in the application indicate that it may be helpful for patients with respiratory distress caused by the virus.
The device is cleared in the U.S. as an adjunctive therapy for acute pain associated with migraines and holds the CE Mark for certain respiratory indications, including treating and preventing symptoms of reactive airway disease.