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MCRA Helps Noctrix Secure Authorization for RLS Therapy

MCRA LLC assisted Noctrix Health in obtaining FDA marketing authorization for the NTX100 Tonic Motor Activation System for patients with RLS.

Shri raghunathanJohn doucetOffice of neurologicalDrug administrationNoctrix healthMotor activationPhysical medicine devices

MCRA Assists Noctrix Health with FDA Marketing Authorization via the De Novo Pathway for the NTX100 Tonic Motor Activation System

/PRNewswire/ MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating U.S. and.

United statesNew yorkShri raghunathanAlyssa howardJohn doucetDigital healthDrug administrationViscogliosi brothersRegulatory affairsClinical research organizationCenters for diseaseNoctrix healthBusiness developmentInternational regulatory affairsOffice of neurologicalClinical trial operations

FDA grants de novo status to restless legs syndrome therapy

The FDA has granted Noctrix Health its de novo request for the NTX100 Tonic Motor Activation System, the first therapy for patients with moderate to severe, drug-refractory restless legs syndrome, according to a company press release.

Heather bieleShri raghunathanRichard boganUniversity of south carolina school medicineNoctrix healthMotor activation systemMotor activationSouth carolina schoolBogan sleep consultants

Prescription Device Cleared for Patients With Drug-Resistant Restless Legs Syndrome

The FDA has cleared the NTX100 Tonic Motor Activation System for the treatment of medication-refractory moderate to severe RLS.

United statesAsim royDrug administrationOhio sleep medicine instituteMotor activationClinician appClinical global impressions improvementPrincipal investigatorPrincipal investigatorsMedical directorOhio sleep medicine

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

/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.

United statesMark buchfuhrerRichard boganShri raghunathanAsim royOhio sleep medicine instituteNoctrix health incDrug administrationNoctrix healthBogan sleep consultantsPrnewswire noctrix healthMotor activationPrincipal investigatorClinical associate professorSouth carolina schoolPrincipal investigators

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