Noctrix Health announces successful randomized controlled trial (RCT) outcomes and FDA Marketing Authorization for its Breakthrough Tonic Motor Activation (TOMAC) Restless Legs Syndrome (RLS) Therapy

PLEASANTON, Calif., April 19, 2023 /PRNewswire/ — Noctrix Health announced that the U.S. Food and Drug Administration (FDA) has granted its De Novo request for the NTX100 Tonic Motor Activation (TOMAC) System to treat symptoms of moderate-severe RLS and improve sleep quality in patients refractory to medications. The FDA had previously granted a “Breakthrough Device Designation” for this therapy in May 2020. The prescription therapy includes a pair of devices worn on the lower legs that electrically activate the peroneal nerves bilaterally to produce tonic, sustained muscle activation that is compatible with sleep to suppress symptoms of RLS.

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