Neuronetics Receives 510(k) Clearance for NeuroSite™ Coil Placement Accessory
18 Dezembro 2023 - 10:49AM
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 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.
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:EvolveMKD646.517.4220NeuroStar@evolvemkd.com
1 Data on file, Neuronetics 2023
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