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# FDA Clears Relivion System for Migraine Treatment
- URL: https://www.fdaweb.com/fda-clears-relivion-system-for-migraine-treatment/
- Published: 2021-03-02T12:00:00.000Z
- Updated: 2026-09-14T16:48:59.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148781

FDA has cleared Neurolief’s Relivion system, the first non-invasive, multi-channel brain neuromodulation system for at-home treatment of acute migraine. The company [says](https://www.businesswire.com/news/home/20210302005356/en/Relivion%C2%AE-Wearable-Brain-Neuromodulation-Technology-Cleared-by-FDA-for-the-Treatment-of-Migraine?ref=fdaweb.com) that Relivion, worn as a headset, demonstrated statistically significant efficacy in providing complete freedom of migraine symptoms within two hours after treatment.

The agency’s marketing clearance was based on the results of a multi-center study in which 46% of the patients in the active group reached complete pain freedom compared to 11.8% of patients in the control group. No serious adverse events were reported, Neurolief says.