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Date de publication 19/12/2024

DEYMED Achieves MDR Certification for DuoMAG TMS Systems

DEYMED Achieves MDR Certification for DuoMAG TMS Systems

We are pleased to announce that DEYMED, as one of the first manufacturers of TMS magnetic stimulators, has successfully obtained MDR certification for our DuoMAG system range designed for transcranial magnetic stimulation.

This significant milestone confirms our commitment to providing physicians, researchers, and patients with the highest standards of quality, safety, and effectiveness.

What is MDR?
The European Parliament and Council Regulation (EU) 2017/745 on Medical Devices (MDR), which replaced the Medical Devices Directive (MDD), introduced stricter requirements to demonstrate the safety and effectiveness of medical devices throughout their entire lifecycle. Meeting these requirements confirms that the DuoMAG systems deliver maximum reliability, safety, and clinical efficacy.

DuoMAG TMS System Range
DuoMAG offers a broad portfolio of versatile TMS systems designed for both clinical and research applications. Each system is engineered to support diagnostic and therapeutic protocols across neurological and psychiatric indications. Our key DuoMAG systems include:

  • DuoMAG XT: Biphasic rTMS system suitable for a wide range of clinical and research applications.
  • DuoMAG XTR: Biphasic rTMS system with an extended range of stimulation parameters, optimized for efficient use in even the most demanding applications.
  • DuoMAG MP: Monophasic TMS system, enabling diagnostic applications and advanced research.
  • DuoMAG MP-Dual: Monophasic TMS system for advanced clinical and research applications.

MDR-Approved Indications
With the new certification, the DuoMAG range now includes a broader spectrum of approved indications, further expanding its benefits in clinical practice.

Therapeutic Indications:

  1. Major Depressive Disorder (MDD)
  2. Neuropathic Pain
  3. Post-traumatic stress disorder (PTSD)
  4. Obsessive-compulsive disorder (OCD)
  5. Nicotine craving
  6. Methamphetamine, amphetamine craving
  7. Drug addiction and behavioral addiction
  8. Schizophrenia – Auditory Hallucinations
  9. Schizophrenia – Negative symptoms

Diagnostic Indications:

  1. Upper motor neuron disorder
  2. Lower motor neuron disorder
  3. Combined upper and lower motor neuron disorder
  4. Psychiatric disorder

Future Commitment
DEYMED will continue to support research and development to remain a leader in neuromodulation therapies and provide healthcare professionals and patients with reliable and effective solutions.

For more information about the DuoMAG range, MDR certification, or newly approved indications, please contact our team.