Neuronetics Receives 510(k) Clearance for OCD MT Cap for NeuroStar Advanced Therapy
12 Junho 2023 - 9:59AM
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 today that they have received
510(k) clearance for their obsessive-compulsive disorder (OCD)
Motor Threshold (MT) Cap technology for NeuroStar® Advanced Therapy
for Mental Health.
“This FDA clearance underscores our commitment to delivering the
latest technology that will streamline the treatment process for
our customers,” shared Cory Anderson, SVP of R&D and Clinical
at Neuronetics. “The unique design and functionality of the OCD MT
Cap will enable clinicians to optimize treatment efficiency while
upholding the highest standard of care for their patients. This
innovation also prepares NeuroStar for even further technological
advancements expected later this year and next.”
Determining a patient’s Motor Threshold (MT) is a critical step
to establish the patient’s prescription prior to starting
treatment. NeuroStar stands out as the only TMS system with FDA
clearance for MT Caps designed for both OCD and major depressive
disorder (MDD). The MT Cap simplifies the initial NeuroStar
coil placement by providing a consistent starting location and a
step-by-step process to map a patient's motor cortex, effectively
shortening the time and reducing the number of steps involved. The
OCD MT Cap shares the same advantages as the current MDD MT Cap.
This includes its compatibility with Fast MT™, providing up to a
40% time savings for clinicians and patients during the initial
visit.
“The current MT Cap for depression became an immediate staple in
my practice, and I have witnessed its numerous benefits firsthand.
I am thrilled with the addition of the FDA-cleared MT Cap for OCD,”
said Dr. Kenneth Pages, Medical Director at TMS of South Tampa.
“This new technology is an important development, as it will
further empower my practice to provide effective and personalized
care for individuals struggling with OCD.”
Nearly 300 patients with OCD have received treatment with
NeuroStar TMS, with over 6,000 treatments delivered. The OCD MT Cap
will be available at select sites starting this month, with
nationwide availability expected in Q4. For more information
about NeuroStar, please visit NeuroStar.com.
About NeuroneticsNeuronetics,
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 5.4 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:EvolveMKD646.517.4220NeuroStar@evolvemkd.com
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