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Theranica, an Israeli prescription digital therapeutics developer for migraine and other pain conditions, has received 510(k) clearance from the U.S. Food and Drug Administration for its Nerivio device.
The device has been cleared for acute treatment of episodic or chronic migraine in people 12 years and older.
Nerivio is a wireless, noninvasive remote electrical-stimulation wearable that is worn on the upper arm at the onset of a migraine. Each treatment session is 45 minutes long and uses remote electrical neuromodulation to activate the brain s native conditioned pain modulation mechanism to treat pain and associated migraine symptoms.
Users control the device with an accompanying app that can adjust the stimulation intensity, monitor the treatment duration and pause or stop treatment if needed. Within the app, users can track their migraines using a diary feature that records treatment sessions, pain levels and related symptoms. From there, users can share their mig