FDA Clears neurocare’s TMS Therapy Devices for OCD Treatment

neurocare group AG has secured U.S. Food and Drug Administration (FDA) clearance for treating Obsessive Compulsive Disorder (OCD) with its Apollo TMS Therapy devices, a state-of-the-art system in Transcranial Magnetic Stimulation.

OCD affects about 1.2% of U.S. adults in any given year, and approximately 2.3%—roughly one in 40 people—experience it at some point in their lifetime. Symptoms can include obsessive thoughts such as fears of contamination, harm, forbidden ideas, or need for symmetry, and compulsive behaviors like excessive cleaning, checking, arranging, mental rituals, or repeated reassurance seeking. These patterns can seriously impact the quality of a person’s daily life.

TMS Therapy is a non-invasive, evidence-based treatment modality already FDA-cleared for patients with Major Depressive Disorder (MDD). For patients suffering from OCD, treatment options have been largely limited to cognitive behavioral therapy and medications like SSRIs, which often have modest success and high drop-out rates; only about 30% of patients continuing with treatment long term. This new FDA clearance gives clinicians a much-needed tool, and a drug-free alternative for patients who have few effective treatment options.

TMS Therapy uses a strong magnetic field produced by a specialized coil that is placed on the head to stimulate targeted brain pathways. neurocare’s Apollo TMS Therapy systems support advanced treatment protocols that are well-suited for OCD treatment approaches, providing symptom relief for patients, thus enhancing the quality of life for this population.

“With this new FDA clearance, we can help more people living with OCD access a safe and effective, non-drug treatment option that can make a real difference in their daily lives. Our Apollo TMS Therapy technology sets a new standard of care in the treatment of OCD, empowering clinicians to deliver the highest level of patient care.” said Stanford Miller, managing director of neurocare group’s North American operations.

Since 2021, neurocare has installed more than 300 Apollo systems in U.S. clinics and large institutions which have been used to treat challenging cases of MDD. Apollo TMS Therapy is FDA-cleared for the treatment of MDD in patients who have had an inadequate response to oral antidepressants.

neurocare group AG has developed a best practice mental health platform, empowering clinicians to offer their patients, through personalized therapy, the best care for various psychological or neurological conditions with more sustainable clinical outcomes. These therapy plans integrate 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 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 United States, the U.K., the Netherlands, and Australia, as well as in a growing number of third-party clinics.