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Neuronetics Granted Regulatory Approval (510(k) Clearance) for Innovative NeuroSite™ Coil Placement Accessory

Monday, December 18, 2023

Neuronetics, a forward-thinking medical technology company committed to enhancing the lives of patients with neurohealth disorders, has announced the successful clearance by the U.S. Food and Drug Administration for its innovative NeuroSite™ Coil Placement Accessory. This advanced tool is designed to streamline the measurement and positioning of coils during NeuroStar transcranial magnetic stimulation (TMS) treatments.

The proprietary NeuroSite™ Coil Placement Accessory prioritizes versatility and provider convenience, seamlessly integrating with both existing and new NeuroStar systems. This clearance marks the latest in a series of advancements aimed at improving patient care, demonstrating Neuronetics' unwavering dedication to advancing medical technology in the mental health domain.

By capitalizing on each patient's unique anatomical features, the NeuroSite™ accessory ensures precise and reproducible coil placement. This not only simplifies the NeuroStar TMS process with significantly fewer patient setup steps but also enhances efficiency for providers' offices, all while maintaining the accuracy established by the current NeuroStar Head Support System (HSS).

Set to be available to all NeuroStar providers in the first quarter of 2024, the NeuroSite™ Coil Placement Accessory represents a significant step forward in optimizing the TMS treatment process and raising the standard of care in neurohealth.


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