BETA
Wearable neurostimulation therapy for adults with drug-refractory restless legs syndrome.
Noctrix Health commercializes Nidra, a wearable neurostimulation system for restless legs syndrome. The therapy uses tonic motor activation delivered through devices worn near the knees, targeting peripheral nerves as a non-drug treatment approach.
FDA granted the Nidra system De Novo authorization in April 2023. Its U.S. indication addresses adults with drug-refractory moderate-to-severe primary restless legs syndrome; the authorization should not be generalized to other neurological conditions.
The Pleasanton-based company is led by Shriram Raghunathan. Its commercial model includes clinician prescribing and patient-access support, making reimbursement execution and patient onboarding relevant alongside device performance.
Nidra’s Tonic Motor Activation system was granted De Novo classification under DEN220059. This is a device-specific authorization for its labeled restless-legs-syndrome population, not a blanket authorization for other neurological conditions. [21][2][16][18][1]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [6][4]
Latest recorded source review: 2026-10-20.
Documented commercial product families.
Bilateral wearable stimulation for drug-refractory primary restless legs syndrome. [21][22]
FDA De Novo grantedCommercially offered; exact model and country availability should be confirmed with the manufacturer.
Commercial U.S. wearable therapy; broader neurological indications are not established. [21]
FDA granted the original Nidra marketing authorization. [22]
Accessed 10/29/2026