Neuronetics Secures FDA Clearance for NeuroSite, Streamlining Mental Health Treatments

Neuronetics, Inc

MALVERN, PA — Neuronetics, Inc. (NASDAQ: STIM) this week announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of its NeuroSite™ Coil Placement Accessory. The state-of-the-art tool, designed to enhance the efficiency and patient experience in NeuroStar transcranial magnetic stimulation (TMS) treatments, is expected to be available to all NeuroStar providers beginning in the first quarter of 2024.

The NeuroSite™ accessory, which seamlessly integrates with both legacy and new NeuroStar systems, simplifies the measurement and positioning of the coil during TMS treatments. By leveraging the patient’s unique anatomical features, the device ensures precise and reproducible coil placement. This innovation streamlines the setup process for NeuroStar TMS treatments, reducing steps and thereby increasing efficiency for providers’ offices while ensuring the accuracy established by the current NeuroStar Head Support System (HSS).

According to Cory Anderson, SVP of R&D and Clinical at Neuronetics, the FDA clearance of NeuroSite™ exemplifies the company’s ongoing commitment to advancing medical technology for mental health. “We are thrilled to introduce yet another innovative accessory to our suite of products that deliver a fast, easy, reliable treatment that both patients and providers trust,” Anderson said.

Medical professionals already using NeuroStar TMS treatments have welcomed the announcement. Dr. Kenneth Pages, Medical Director at TMS of South Tampa, praised the user-friendly nature of NeuroSite™ and the flexibility it brings to patient positioning across all generations of NeuroStar devices. “This latest tool reinforces my confidence in providing consistent results and truly exceptional care to my patients,” said Dr. Pages.

The approval of NeuroSite™ is likely to further solidify Neuronetics’ position in the mental health technology market, providing investors with an optimistic outlook on the company’s future growth. With its commitment to continual advancement and a proven track record of innovative solutions, Neuronetics continues to demonstrate its potential as a leader in the field of mental health treatment technology.

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