Israeli BrainTech startup BrainsWay, which uses deep transcranial magnetic technologies (Deep TMS) to treat brain disease, announced Sunday the approval of the US Food and Drug Administration (FDA) for its non-invasive device treatment Obsessive-compulsive disorder (OCD)
The approval marks the first approval of a non-invasive medical device for the treatment of OCD, according to the company, and the second time BrainsWays system has been approved by the federal agency. In May, Brainsway announced it has received 501 (k) clearance for its new stimulator to be integrated into BrainsWay's Deep Transcranial Magnetic Stimulation (Deep TMS) system for the treatment of Major Depressive Disorder (MDD)
"BrainsWays OCD Certification marks a historic milestone in the treatment of this disorder, providing a new treatment option for patients seeking a meaningful and life-changing OCD solution," said Drs. Joseph Zohar, Professor of Psychiatry at the Sackler School of Medicine at the University of Tel Aviv and Chairman of the International Organization for Obstruction Disorders (ICOCS) and lead author of the OCD study
The company plans to immediately sell and install ODS Brainsway To start helms. These helmets simulate the gray matter in the prefrontal cortex of the brain and attack the eightfold spirals to address various diseases, including OCD,
schizophrenia, bipolar disorder, and autism.
Brainsway was founded in 2003 by Abraham Zangen, Yiftach Roth. Avner Hagai and David Zacut and has been listed on the Tel Aviv Stock Exchange since 2007.