electroCore, Inc., gammaCore Sapphire CV - Letter of Authorization

electroCore, Inc., gammaCore Sapphire CV - Letter of Authorization

Emergency Use Authorization (EUA) Updates

EUAs to improve air flow, provide relief from shortness of breath in asthma patients FDA issued an EUA (PDF) to Electrocore Inc., for its GammaCore Sapphire Non-invasive Vagus Nerve Stimulator. This stimulator is intended for use at home or in health care settings to treat adult patients with known or suspected COVID-19 who are experiencing worsened asthma-related shortness of breath and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief as assessed by the patient’s healthcare provider. The device improves airflow and provides relief from exacerbated asthma-related shortness of breath in such patients. The device is placed on either side of the patient’s neck for two consecutive two-minute stimulations at the onset of respiratory distress or shortness of breath for up to 24 stimulations every 24 hours. (July 10, 2020) FDA also added Circadiance, under the umbrella EUA for ventilators, for its SleepWeaver Prevent CPAP Mask. The product is a CPAP mask that was modified by combining it with an N95. (July 8, 2020)

Diagnostic test EUAs To date, FDA has currently authorized 179 tests under EUAs, which include 148 molecular tests, 29 antibody tests, and 2 antigen tests. Also see: Coronavirus Testing Basics

Related links: FAQs on Testing for SARS-CoV-2 (frequently updated) Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices