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Medical Devices / Submissions and Approvals

Israeli Devicemaker Gains De Novo Clearance for Mobile Migraine Treatment

June 4, 2019
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Theranica has earned De Novo clearance from the FDA for its Nerivio Migra product, a neuromodulation device designed to treat migraines.

The device is placed on the upper arm and emits electrical pulses that are controlled via smartphone. It is indicated for treating migraines with or without aura—a visual, sensory, motor or verbal disturbance—in adults who don’t have chronic migraine.

Clinical data showed that the product “can provide patients with significant relief of pain and other migraine symptoms without the side effects presented by drugs,” said Messoud Ashina, president-elect of the International Headache Society.

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