Neuronetics Receives MDSAP Certification and CE Mark Certification under New MDR

FacebookFacebookTwitterTwitterEmailEmailLinkedInLinkedInWhatsAppWhatsAppMessengerMessengerFlipboardFlipboardGmailGmailTelegramTelegramShareShare

Achievement demonstrates Company’s commitment to rigorous standards for safe and effective products

MALVERN, Pa., May 08, 2023 (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 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 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 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:
EvolveMKD
646.517.4220
NeuroStar@evolvemkd.com

Staff

Recent Posts

NEWBEAUTY RELEASES ‘THE STATE OF AESTHETICS: BY THE NUMBERS SUMMER 2025’

CRANBURY, N.J., July 22, 2025 /PRNewswire/ -- NewBeauty , the definitive authority on all things beauty, has announced…

6 minutes ago

Oncolytics Biotech® Regains Compliance with Nasdaq Trading Rules

SAN DIEGO and CALGARY, AB, July 22, 2025 /PRNewswire/ -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (TSX: ONC)…

6 minutes ago

Former Sandoz Inc. CEO Don DeGolyer Leads PharmaTech Startup Ategenos as Company Prepares Public Launch

Veteran pharma operator co-founded Ategenos to tackle the global $1 trillion crisis of medication non-adherence…

7 minutes ago

Intelligent Health Marketplace Acquires Organization to Improve Transparency and Drive Affordability

MacroHealth Acquires ClearCost Health to Further Improve Healthcare Access, Cost and Quality KIRKLAND, Wash., July…

7 minutes ago

The Kentucky Community and Technical College System (KCTCS) Partners with The Jed Foundation (JED) to Launch Mental Health Plan for 110,000 Students

New framework responds to urgent student needs and builds momentum for statewide action VERSAILLES, Ky.,…

7 minutes ago

Randstad Named Leader and Star Performer in Everest Group PEAK Matrix® Assessment 2025 for US Contingent Talent and Strategic Solutions – Industrial

Double recognition reinforces Randstad's strength as an innovative partner for specialized workforce solutions in the…

7 minutes ago