Neuronetics Receives 510(k) Clearance for NeuroSite™ Coil Placement Accessory

Rhea-AI Summary

Neuronetics, Inc. (NASDAQ: STIM) announced the FDA 510(k) clearance of NeuroSite™ Coil Placement Accessory, a tool that simplifies measurement and coil positioning during NeuroStar TMS treatments. The accessory integrates with both legacy and new NeuroStar systems, streamlining the TMS process with significantly fewer patient setup steps, improving efficiency for providers and enhancing the patient experience. NeuroSite™ will be available to all NeuroStar providers beginning in Q1 of 2024.

Positive

• FDA 510(k) clearance of NeuroSite™ Coil Placement Accessory
• Seamless integration with both legacy and new NeuroStar systems
• Streamlining the TMS process with significantly fewer patient setup steps
• Improving efficiency for providers’ offices and patient experience
• Precise and reproducible coil placement ensuring accuracy
• Availability to all NeuroStar providers beginning in Q1 of 2024

Negative

• None.

New accessory for NeuroStar TMS reduces patient setup steps and improves efficiency for providers

MALVERN, Pa., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Neuronetics, Inc. (NASDAQ: STIM), a medical technology company focused on designing, developing, and marketing products that improve the quality of life for patients who suffer from neurohealth disorders, announced the U.S. Food and Drug Administration 510(k) clearance of NeuroSite™ Coil Placement Accessory, a state-of-the-art tool that simplifies measurement and coil positioning during NeuroStar transcranial magnetic stimulation (TMS) treatments. This proprietary accessory, designed with versatility and provider convenience in mind, seamlessly integrates with both legacy and new NeuroStar systems and further enhances efficiency and patient experience.

“The NeuroSite™ FDA clearance is the latest of many enhancements designed to improve the patient experience, exemplifying our ongoing commitment to continually advance medical technology for mental health,” stated Cory Anderson, SVP of R&D and Clinical. “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.”

By leveraging the patient's unique anatomical features, NeuroSite™ Coil Placement Accessory ensures precise and reproducible coil placement. This streamlines the NeuroStar TMS process with significantly fewer patient setup steps¹, thereby improving efficiency for providers’ offices and improving the patient experience while maintaining the accuracy established by the current NeuroStar Head Support System (HSS).

“As a NeuroStar TMS provider with multiple systems, I appreciate how user-friendly NeuroSite™ is, along with the flexibility it brings to patient positioning across all generations of NeuroStar devices,” said Dr. Kenneth Pages, Medical Director at TMS of South Tampa. “This latest tool reinforces my confidence in providing consistent results and truly exceptional care to my patients.”

NeuroSite™ will be available to all NeuroStar providers beginning in Q1 of 2024. For more information about NeuroStar TMS Therapy, please visit NeuroStar.com. 

About Neuronetics
Neuronetics, Inc. believes that mental health is as important as physical health. As a global leader in neuroscience, Neuronetics is redefining patient and physician expectations with its NeuroStar Advanced Therapy for Mental Health. NeuroStar is a non-drug, noninvasive treatment that can improve the quality of life for people suffering from neurohealth conditions when traditional medication hasn’t helped. In the United States, NeuroStar is FDA-cleared for adults with major depressive disorder (MDD), as an adjunct for adults with obsessive-compulsive disorder (OCD), and to decrease anxiety symptoms in adult patients with MDD that may exhibit comorbid anxiety symptoms (anxious depression). NeuroStar Advanced Therapy is the leading transcranial magnetic stimulation (TMS) treatment for MDD in adults with over 5.9 million treatments delivered. NeuroStar is backed by the largest clinical data set of any TMS system for depression, including the world’s largest depression Outcomes Registry. Neuronetics is committed to transforming lives by offering an exceptional treatment that produces extraordinary results. For safety and prescribing information, www.neurostar.com.

Media Contact:
EvolveMKD
646.517.4220
NeuroStar@evolvemkd.com

¹ Data on file, Neuronetics 2023

FAQ

What is the FDA 510(k) clearance for NeuroSite™ Coil Placement Accessory?

The FDA 510(k) clearance allows NeuroSite™ Coil Placement Accessory to be marketed and used in the United States.

How does NeuroSite™ improve efficiency for providers?

NeuroSite™ streamlines the TMS process with significantly fewer patient setup steps, improving efficiency for providers’ offices.

When will NeuroSite™ be available to NeuroStar providers?

NeuroSite™ will be available to all NeuroStar providers beginning in Q1 of 2024.

What are the benefits of NeuroSite™ for patient experience?

NeuroSite™ ensures precise and reproducible coil placement, improving the patient experience while maintaining accuracy.

What are the key features of NeuroSite™?

NeuroSite™ is designed with versatility and provider convenience in mind, seamlessly integrating with both legacy and new NeuroStar systems, and bringing flexibility to patient positioning across all generations of devices.