FDA clears OCD motor threshold cap for transcranial magnetic stimulation system
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The FDA has granted 510(k) clearance to Neuronetics Inc. for its obsessive-compulsive disorder motor threshold cap technology for NeuroStar Advanced Therapy for Mental Health.
According to a Neuronetics press release, NeuroStar is a noninvasive transcranial magnetic stimulation system designed to improve quality of life for those with neuro-related health conditions when traditional medication fails to provide relief.
Determining an individual’s motor threshold (MT) is key to establishing their prescription before treatment begins, the company stated. The MT Cap accomplishes this by providing a consistent starting location and a step-by-step mapping process of an individual’s motor cortex, thereby reducing time and number of steps involved in NeuroStar coil placement.
The OCD MT Cap has the same advantages as the company’s major depressive disorder MT Cap, which includes compatibility with Fast MT, providing up to 40% time-savings for patients and clinicians, the release stated.
“This FDA clearance underscores our commitment to delivering the latest technology that will streamline the treatment process for our customers,” Cory Anderson, Neuronetics senior vice president of research and development and clinical, said in the release. “The unique design and functionality of the OCD MT Cap will enable clinicians to optimize treatment efficiency while upholding the highest standard of care for their patients.”
According to the release, NeuroStar is cleared by the FDA for adults with major depressive disorder as an adjunct for adults with OCD and to help reduce anxiety symptoms in adults with major depressive disorder who may also display comorbid anxiety symptoms.
“I am thrilled with the addition of the FDA-cleared MT Cap for OCD,” Kenneth Pages, MD, medical director at TMS of South Tampa, said in the release. “This new technology is an important development, as it will further empower my practice to provide effective and personalized care for individuals struggling with OCD.”