neurocare group AG announces MDMA approval of TMS Devices in Saudi Arabia

Munich, Germany and Riyadh, Saudi Arabia - neurocare group AG (“neurocare” or the “Company”), a best practice platform for mental health and performance, is pleased to announce the Saudi Food & Drug Authority (SFDA) has granted the Company Medical Device Marketing Authorization (MDMA) approval to sell its TMS Devices in the Kingdom of Saudi Arabia.

A core part of neurocare’s best practice platform is TMS technology which offers a safe, non-invasive, and drug-free alternative for mental health indications such as depression, yet with no black box warning and no medication-related side effects. As part of the neurocare platform, TMS is embedded into structured clinical workflows and supported by digital tools and measurement-based care, enabling clinicians to deliver more consistent, personalized and sustainable outcomes.

Clinical studies show that approximately 60% of patients achieve remission with TMS, making it a promising new treatment option for adolescents who have not found success with other treatments for depression. 

This milestone marks a significant step forward in neurocare’s efforts to expand access to its advanced best practice platform across the Middle East. With this approval, neurocare becomes one of the first TMS manufacturers authorized to operate in Saudi Arabia, positioning the Company at the forefront of a rapidly developing mental healthcare landscape.

Saudi Arabia is investing heavily in evidence-based, technology-enabled care through its Health Sector Transformation Program, creating strong momentum for the adoption of innovative treatments such as TMS. Across the wider Gulf region, neurocare has seen growing interest specifically in its integrated platform approach, uniting neuromodulation, digital processes and standardized protocols, which is well aligned with the needs of clinicians and health systems seeking reliable alternatives.

With MDMA approval now secured, neurocare is uniquely positioned to bring its proven, state-of-the-art platform led by TMS technology to providers in the Kingdom. This enables clinics to expand their service offerings, improve treatment outcomes, and deliver personalized, nonpharmacological care to patients who need it most.

“We see tremendous potential across the region for adopting innovative, evidence-based methods such as TMS,” said Tariq El-Titi, Senior Vice President for neurocare in MENA. “Healthcare leaders in Saudi Arabia are increasingly looking for advanced, nonpharmacological solutions to support patients. We look forward to forming new partnerships across the Kingdom and supporting clinicians as they integrate best-practice TMS therapies powered by German-engineered technology.”

“This approval reflects our broader mission to empower clinicians through our best practice platform with our TMS technology first,” said Thomas Mechtersheimer, Founder and CEO of neurocare group AG. “By combining advanced neuromodulation, digital tools, and integrated processes, we enable providers to deliver more personalized care and achieve better outcomes for patients across the region.”

“With SFDA approval in place, the priority now is execution—embedding TMS within clinical pathways and expanding access beyond traditional hospital settings,“ added Dr. Helmut Schuehsler, CEO and Chairman of TVM Capital Healthcare. “We look forward to continuing to work closely with partners and regulators to adapt and scale proven platforms such as neurocare’s to the Kingdom’s needs and support growing mental health demand.”

neurocare has been active in the MENA region since 2024 through strategic partnerships that support the expansion of best-practice mental healthcare, complementing the company’s established clinical footprint across Europe, the US, the UK, the Netherlands and Australia. Following TVM Capital Healthcare’s investment, the Company has accelerated its regional expansion, working closely with local partners and regulators to establish and scale its integrated platform that provides neuromodulation and neurofeedback technologies and clinical care in Saudi Arabia. In parallel, neurocare continues to advance access to evidence-based neuromodulation by supporting global efforts to secure reimbursement pathways for TMS and related technologies.

At a time when regional dynamics underscore the importance of resilient healthcare systems that are inclusive of mental well-being, neurocare’s platform can support patients and providers during periods of heightened need with reliable, locally accessible, and personalised care solutions.

About neurocare group AG

neurocare group AG has developed a best practice mental health platform, empowering clinicians to offer their patients, through personalized therapy, the best care for a variety of psychological or neurological conditions with more sustainable clinical outcomes. These therapy plans integrate innovative methods and tools, such as psychotherapy, neuromodulation, and sleep hygiene, as well as medication. Following a detailed assessment of the patient's condition, neurocare supports clinicians in developing personalized therapy plans that improve self-regulation, resilience and social skills, while being cost-effective for the healthcare system.

The key technology elements of neurocare’s platform are developed in-house, including leading TMS and EEG devices, a cloud-based software platform, as well as an online academy to give professionals the tools and neuroscientific understanding to properly apply these approaches in clinical practice.

neurocare’s platform is currently applied throughout the company’s own clinics across the US, the UK, the Netherlands and Australia, as well as in a growing number of third-party clinics.

neurocaregroup.com

Contact:

Sally Remington
neurocare group AG
media@neurocaregroup.com

About TVM Capital Healthcare

TVM Capital Healthcare is a global private equity investor and operator focused on specialty care and healthcare growth capital across emerging markets. With nearly 40 years of global investment and operational experience and 15 years in emerging markets, the firm builds and scales companies in Southeast Asia and the Middle East while also investing in healthcare innovators from the US and Europe and guiding their expansion into these markets. TVM Capital Healthcare’s portfolio companies advance access to care, improve patient outcomes, and align with national healthcare transformation agendas.

tvmcapitalhealthcare.com

Contact:

Holly Radel
TVM Capital Healthcare
radel@tvmcapitalhealthcare.com

Attachment

• Patient Receives Depression Treatment Using neurocare’s Apollo TMS System

Legal Disclaimer:

EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.