Neurolief’s Neuromodulation Device Receives Japanese Approval for At-Home Migraine Treatment

The Japanese Ministry of Health, Labor and Welfare (MHLW) has granted approval for the at-home use of Neurolief’s neuromodulation device, Relivion, in the acute treatment of migraines. This US-based company’s non-invasive technology is designed to address the neural pathways responsible for debilitating migraine headaches, offering a new option for individuals seeking relief from this condition.

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Relivion’s Innovative Neuromodulation Technology

Relivion stands out as a multi-channel brain neuromodulation device that targets the occipital and trigeminal nerve branches. These neural pathways are key contributors to the onset of migraines. The technology, which has two versions – RelivionMG for migraines and RelivionDP for major depressive disorder (MDD) – has already received clearance for the treatment of acute migraines from regulatory bodies such as the US Food and Drug Administration (FDA). The device is part of a growing field of neuromodulation treatments that are reshaping the landscape of migraine care.

The approval of Relivion in Japan highlights the growing interest and acceptance of neuromodulation as a viable treatment option for migraines. With features such as AI integration, remote monitoring capabilities, and connectivity to a mobile app, Relivion aims to offer patients a comprehensive solution for managing their migraines at home. The competitive landscape includes other neuromodulation devices like Theranica Bioelectronics’ Nerivio, which gained FDA approval in 2019, and Salvia BioElectronics’ breakthrough device designated implantable neurostimulation system for severe migraines.

Future Prospects and Regulatory Pathways

Neurolief’s expansion efforts continue as the company seeks further regulatory clearances. While RelivionMG has secured approvals for migraine treatment, Neurolief is actively pursuing FDA clearance and a European CE mark for RelivionDP as a treatment for major depressive disorder (MDD). The convergence of technology, neuroscience, and regulatory pathways positions neuromodulation as an evolving frontier in addressing not only migraines but also mental health conditions, paving the way for innovative and accessible treatment options.

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Author

Sinead Huang