www.fdanews.com/articles/185440-electrocore-snags-new-use-indication-for-portable-migraine-therapy-technology
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electroCore Snags New Use Indication for Portable Migraine Therapy Technology
January 31, 2018
Bioelectronic medicine company electroCore achieved 510(k) clearance from the FDA for a new use indication on its gammaCore therapy technology.
The new clearance allows for the noninvasive neuromodulation treatment to be used for treating acute migraine-associated pain in adult patients. The FDA previously cleared gammaCore for treating pain associated with adult episodic cluster headache.
Self-administered treatment can be delivered through a hand-held unit designed to provide mild electric stimulation to the vagus nerves through a patient’s skin.