DEYMED Expands EU MDR Certification for DuoMAG TMS Range with New Clinical Indications

We are pleased to announce that DEYMED has successfully expanded our MDR certification to cover a significantly broader range of certified indications for our DuoMAG system range designed for transcranial and peripheral magnetic stimulation.

This major milestone underscores our commitment to providing physicians, researchers, and patients with non-invasive neuromodulation technology that meets the requirements of Regulation (EU) 2017/745 for quality, safety and clinical performance.

Key Highlight: Expansion of Certified MDR Indications

With our latest certification extension, the DuoMAG TMS range expands beyond traditional psychiatric applications into neurorehabilitation and urology, where a dedicated coil is used for pelvic floor magnetic stimulation (rPMS).

Newly certified MDR indications include:

Bipolar disorder
Post-stroke upper limb dysfunction
Post-stroke aphasia
Post-stroke cognitive impairment
Urinary incontinence (Stress, urge, mixed)

Complete List of Certified Indications

Therapeutic Indications:

Major Depressive Disorder (MDD)
Bipolar disorder (NEW)
Neuropathic Pain
Post-traumatic stress disorder (PTSD)
Obsessive-compulsive disorder (OCD)
Nicotine craving
Methamphetamine, amphetamine craving
Drug addiction and behavioral addiction
Schizophrenia - Auditory Hallucinations
Schizophrenia - Negative symptoms
Post-stroke upper limb dysfunction (NEW)
Post-stroke aphasia (NEW)
Post-stroke cognitive impairment (NEW)
Urinary incontinence (Stress, urge, mixed) (NEW)

Diagnostic Indications:

Upper motor neuron disorder
Lower motor neuron disorder
Combined upper and lower motor neuron disorder
Psychiatric disorder

Diagnostic indications require the stimulator to be used together with an evoked potentials evaluator, such as the TruTrace EMG.

What is EU 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 performance of medical devices throughout their entire lifecycle. Meeting these rigorous requirements confirms that the safety, performance and clinical benefit of DuoMAG systems have been demonstrated and independently assessed by the notified body.

DuoMAG TMS System Range

DuoMAG offers a broad portfolio of versatile TMS systems designed for both clinical and research applications. The systems support diagnostic and therapeutic protocols across neurological, psychiatric and urological indications:

DuoMAG XT: Biphasic rTMS and rPMS system suitable for a wide range of clinical and research applications.
DuoMAG XTR: Biphasic rTMS and rPMS 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.

Our Future Commitment

DEYMED will continue to invest in research and development to remain a leader in neuromodulation therapies, empowering healthcare professionals and patients with state-of-the-art solutions.

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

DuoMAG is a medical device for use by healthcare professionals. Read the instructions for use and the safety information before use. CE marking under Regulation (EU) 2017/745; notified body 3EC International, NB 2265. Availability differs between countries.