Monarch eTNS System
Commercial- Indications
- ADHD
Company intelligence / Profile preview
NeuroSigma's Monarch eTNS System has FDA clearance as a non-drug monotherapy for pediatric ADHD. The company has also received Breakthrough Device Designation from the FDA for drug-resistant epilepsy. Early clinical data suggest efficacy in additional neurodevelopmental disorders such as ASD and dyslexia. The system has CE Mark approval in Europe for adjunctive treatment of epilepsy and major depressive disorder. No serious adverse events have been reported with use of their devices.
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