Neuronetics Announces 510(k) Clearance of D-Tect™ MT Accessory for NeuroStar® Advanced Therapy for Mental Health

MALVERN, Pa., Aug. 29, 2022 (GLOBE NEWSWIRE) — Neuronetics, Inc. (NASDAQ: STIM), 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 for their D-Tect™ MT Accessory, which is the latest innovation in NeuroStar’s commitment to simplify the motor threshold determination for physicians. The FDA-cleared technology aids clinicians by visually reporting the magnitude of finger movements during motor threshold (MT) mapping for treatment of major depressive disorder (MDD). D-Tect also allows the MT determination to be performed by only one person. The D-Tect MT Accessory will initially be available via a limited commercial launch, with a national rollout beginning in mid-September. In addition, practices will be trained on this new product at NeuroStar University, which recently opened in Charlotte, North Carolina. 

“The FDA clearance for the D-Tect MT Accessory is the next chapter in our plan to simplify and accelerate the MT determination for NeuroStar providers,” stated Cory Anderson, VP of R&D and Clinical. “This product aids physicians as they determine the treatment location and treatment level for new patients, and we’re excited to announce that this patent-pending technology is compatible with all new and existing NeuroStar systems.”

The D-Tect MT Accessory is designed to recognize the movement in three areas of the hand, and it does not require cords or sensors to be attached to the patient. This streamlines the process compared to the current visual method and provides the clinician with more data, including a comparison of the response to the current versus previous pulse. The D-Tect MT Accessory complements NeuroStar’s Fast MT™ and the MT Cap innovations, completing the solution for determining the motor threshold, and delivering an average time savings of 40% for physicians during the MT determination.

“It’s outstanding to see tangible results from NeuroStar’s ongoing commitment to invest in product innovations that deliver real value to practices like mine by streamlining the entire NeuroStar TMS treatment process,” said David Sikowitz, MD of The TMS Center of New Jersey. “Having the latest technology to assist in determining a patient’s motor threshold will make my team more efficient while also allowing us to deliver the best patient care by personalizing each patient’s treatment while saving time.”

The D-Tect MT Accessory is compatible across all NeuroStar systems. For more information on NeuroStar, please visit neurostar.com.

About D-Tect™ MT Accessory
The D-Tect™ MT Accessory is intended to be used as an accessory of the NeuroStar System to aid in the detection of hand movement and amplitude during motor threshold determination for the treatment of major depressive disorder (MDD).

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. 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 4.8 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.

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