Neuronetics Announces FDA Clearance of MT Cap Technology for NeuroStar Advanced Therapy for Mental Health


Neuronetics, Inc., a commercial stage medical technology company focused on designing, developing, and marketing products that improve the quality of life for patients who suffer from neurohealth disorders, announced today that they have received 510(k) clearance on their MT Cap technology for NeuroStar® Advanced Therapy for Mental Health. A limited launch of the technology will begin in the coming weeks, with a national rollout in Q1 2022.

“We’re delighted to bring to market this latest in a series of technologies designed to make the motor threshold determination process simpler and more efficient for clinicians,” stated Cory Anderson, VP of Clinical Affairs and Medical Operations. “We appreciate the ongoing collaboration with FDA that enabled a quick and efficient review process.”

The MT Cap provides a target starting location and step-by-step map to guide the process of identifying a patient’s motor threshold (MT) and reduce multiple steps during the initial assessment for NeuroStar. The MT Cap leverages NeuroStar’s unique floating coil locking system, making mapping and determining motor thresholds seamless. Determining and locating a patient’s motor threshold is a critical component of the treatment process and can take up to 30 minutes for each patient. Now, when the MT Cap is combined with the recently launched Fast MT, these technology innovations provide an average 40% time savings during the MT activity.

NeuroStar is the leading transcranial magnetic stimulation (TMS) treatment for major depressive disorder, with over 4 million treatments delivered and thousands of lives transformed.

About Neuronetics
Neuronetics, Inc. believes that mental health is as important as physical health. As a global leader in neuroscience and the largest TMS company in the industry, Neuronetics is redefining patient and physician expectations by designing and developing products that improve the quality of life for people suffering from psychiatric disorders. An FDA-cleared, non-drug, noninvasive treatment for people with depression, Neuronetics’ NeuroStar® Advanced Therapy system is today’s leading transcranial magnetic stimulation (TMS) treatment for major depressive disorder with over four million treatments delivered. NeuroStar is widely researched and 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 option that produces extraordinary results.