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BrainsWay recently received de novo clearance from the U.S. Food and Drug Administration (FDA) for its deep transcranial magnetic stimulation (Deep TMS) system for treating obsessive compulsive disorder (OCD) in adults.
Brainsway is an Israel-based medical device company. The Deep TMS system is a noninvasive medical device for treating OCD in adults designed to maximize electromagnetic stimulation in deep and broad regions of the brain.
In a study conducted by BrainsWay, 38.1 percent of patients in the active group saw a 30 percent reduction in their symptom severity, and 54.8 percent of patients in the active group saw a more than 20 percent reduction in symptom severity.
BrainsWay plans to upgrade its current Deep TMS systems by installing the treatment. Clinics with the systems will then be able to treat OCD patients.
“With the clearance of our BrainsWay OCD device, we are now able to provide an effective and safe treatment option for U.S. patients who are suffering from OCD,” BrainsWay President and CEO Yaacov Michlin said in a release. “With more than two million U.S. adults suffering from OCD, this clearance provides us with a significant market opportunity. Importantly, this clearance further establishes Deep TMS as a platform technology that will provide treatments for additional psychiatric indications, subject to successful completion of our currently ongoing multi-center studies and regulatory approvals.”
Danielle covers Clinical Innovation & Technology as a senior news writer for TriMed Media. Previously, she worked as a news reporter in northeast Missouri and earned a journalism degree from the University of Illinois at Urbana-Champaign. She's also a huge fan of the Chicago Cubs, Bears and Bulls.