Neuronetics Receives MDSAP Certification and CE Mark Certification under New MDR
08 Maio 2023 - 9:47AM
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 its certification in two
enhanced compliance programs. The Company has received CE Mark
Certification for NeuroStar Advanced Therapy under the new Medical
Device Regulation (MDR) in the European Union (EU) and the Medical
Device Single Audit Program (MDSAP) certification.
“Underscoring our commitment to rigorous regulatory and quality
standards, our team has worked tirelessly to achieve these
certifications from global regulatory agencies,” said Keith J.
Sullivan, President and CEO of Neuronetics. “These enhanced
compliance standards lay the foundation for the company’s future as
a global organization with the potential to help patients
worldwide.”
The EU MDR is a more stringent certification process that
replaces the European Medical Device Directive. The process is
designed to improve patient safety and ensure the effectiveness and
quality of medical devices sold in the EU. It sets rigid
requirements for developing, manufacturing, and marketing medical
devices. The CE Mark is a symbol that indicates conformity with EU
regulations, and it is a mandatory requirement for medical devices
to be sold in the EU.
MDSAP certification covers distribution in five countries,
including the U.S., Japan, Canada, Australia, and Brazil. Once a
company is registered in the country, MDSAP certification
streamlines the audit process by allowing medical device
manufacturers to undergo a single regulatory audit of their quality
management system that fulfills the requirements of multiple
regulatory jurisdictions.
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 5.3 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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