FDA grants De Novo clearance to smartphone-controlled acute migraine-relief device

Nerivio Migra®, a first-in-category product, is placed on the upper arm (not the head or neck) and uses smartphone-controlled electronic pulses to create a Conditioned Pain Modulation (CPM) response.

Theranica, an Israel-based biomedical technology company focused on developing advanced electroceuticals for migraine and other prevalent diseases, announced on May 28 that the U.S. Food and Drug Administration (FDA) granted a De Novo request for its smartphone-controlled electroceutical, Nerivio Migra®, utilising Remote Electrical Neuromodulation for the acute treatment of migraine.

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