This device has not undergone the same type of review as an FDA-approved or cleared device. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, or available alternatives. In addition, the FDA decision is based on the totality of scientific evidence available showing that it is reasonable to believe that the device meets certain criteria for safety, performance, and labeling, and that it may be effective in treating patients with COVID The EUA for the gammaCore Sapphire CV device is in effect for the duration of the COVID declaration justifying emergency use of these devices, unless terminated or revoked after which the products may no longer be used. Further information is available at:. For more information, visit www. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product: www. This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of Such forward-looking statements include, but are not limited to, statements about electroCore's business prospects and clinical and product development plans, its pipeline or potential markets for its technologies, the timing, outcome and impact of regulatory, clinical and commercial developments including commercialization of, and potential reimbursement for, gammaCore Sapphire CV, potential human trials for the study of nVNS in COVID patients in Spain, the U.
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P, Giannakopoulos. G, Blake. J, Liebler. E, Levy. April 27, This device has not undergone the same type of review as an FDA-approved or cleared device. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, or available alternatives.
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This device has not undergone the same type of review as an FDA-approved or cleared device. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, or available alternatives. In addition, the FDA decision is based on the totality of scientific evidence available showing that it is reasonable to believe that the device meets certain criteria for safety, performance, and labeling, and that it may be effective in treating patients with COVID The EUA for the gammaCore Sapphire CV device is in effect for the duration of the COVID declaration justifying emergency use of these devices, unless terminated or revoked after which the products may no longer be used. For more information, visit www. About gammaCoreTMgammaCoreTM nVNS is the first non-invasive, hand-held medical therapy applied at the neck to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin.
