gammaCore SapphireTM CV (nVNS) receives Emergency Use Authorization (EUA) to treat patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow.

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gammaCore SapphireTM CV has neither been cleared nor approved for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, by using non-invasive Vagus nerve Stimulation (nVNS) on either side of the patient’s neck during the Coronavirus Disease 2019 (COVID-19) pandemic.

gammaCore SapphireTM CV has been authorized for the above emergency use by FDA under an Emergency Use Authorization.

gammaCore SapphireTM CV has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked.