Japan approves first domestic neurostimulation device for depression — Neuropace partner NIPRO launches rTMS
Summary
Japan's PMDA approved the NIPRO NeuroStar rTMS system for major depressive disorder — the first domestically manufactured TMS device cleared in Japan. Developed in partnership with Neuronetics, the device allows Japan to reduce dependence on imported TMS systems and positions NIPRO as a distribution platform for Neuronetics' adolescent depression indication pending PMDA filing.
Why it matters
PMDA approval for a domestically manufactured TMS device accelerates market expansion in Japan's large but conservative mental health device market. The NIPRO partnership gives Neuronetics a local manufacturing and distribution footprint that is essential for the Japanese healthcare procurement system.
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