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# Noctrix ‘Breakthrough’ Device for Restless Legs Syndrome
- URL: https://www.fdaweb.com/noctrix-breakthrough-device-for-restless-legs-syndrome/
- Published: 2020-06-03T12:00:00.000Z
- Updated: 2026-09-14T16:16:57.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146922

FDA has granted Noctrix Health a Breakthrough Device Designation for its wearable NTX100 neuromodulation therapy designed for treating adults with primary moderate-severe restless legs syndrome (RLS) who are refractory to medications. RLS is the second most common sleep disorder in the world and impacts over 10% of the adult population in the U.S, with about three million cases each year, according to the company. It is mainly treated using dopaminergic drugs. Noctrix Health says its device aims to treat RLS symptoms with its wearable neuromodulation platform that targets specific peripheral nerve fibers, and it is comfortable to wear to sleep.