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Medical Devices / Submissions and Approvals

electroCore Snags New Use Indication for Portable Migraine Therapy Technology

Feb. 1, 2018
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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.

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