NeuroStar TMS Secures Enhanced Regulatory Clearance in Japan

Tuesday, December 05, 2023

Neuronetics, a company specializing in medical technology to enhance the well-being of patients with neurohealth disorders, has received approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for various proprietary enhancements in the NeuroStar TMS (transcranial magnetic stimulation) Therapy System. 

The approval covers the NeuroStar 3.7 platform, MT Cap, D-Tect™ MT Accessory, and the Dash treatment protocol. Notably, the Dash protocol significantly reduces daily TMS treatment time from 38 to under 19 minutes. MT Cap and D-Tect improve efficiency for both providers and patients by simplifying the process of determining a patient's motor threshold (MT), a crucial step in establishing the treatment prescription. 

The NeuroStar 3.7 platform aligns with Neuronetics' global standardization strategy and includes enhancements such as 60% more computing power and a touchscreen display with a biometric fingerprint reader, streamlining clinician workflows. This regulatory approval in Japan complements NeuroStar's recent global advancements, including approvals in South Korea, EU-MDR, and MDSAP certifications. NeuroStar remains dedicated to advancing global mental health care, actively seeking approvals for new technological innovations and indications in select international markets as supporting data becomes available.