Brain scan (illustrative).
(photo credit: ING IMAGE/ASAP)
Israel’s BrainsWay Ltd., which creates advanced non-invasive treatment for brain disorders, announced on Sunday that it has received de novo clearance from the US Food and Drug Administration (FDA) for its deep transcranial magnetic stimulation (Deep TMS) system for the treatment of obsessive-compulsive disorder (OCD) in adults.
This clearance represents the first ever non-invasive medical device clearance for the treatment of OCD. BrainsWay intends to start using the approved system as an upgrade for its current systems and as part of new installations. Clinics that have or will have a Deep TMS systems can now treat patients with major depressive disorders (MDD) and OCD.
“With the clearance of our BrainsWay OCD device, we are now able to provide an effective and safe treatment option for US patients who are suffering from OCD,” said Yaacov Michlin, the president and chief executive officer of BrainsWay. “With more than two million US 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.”
BrainsWay’s Deep TMS technology differs from that of other focal TMS devices as it has broad applicability and can directly stimulate areas of the brain at a greater depth and breadth than any other TMS device on the market safely and efficiently.
While other focal TMS devices are limited to treating MDD, BrainsWay can now directly target previously unreachable areas of the brain with its proprietary H7-coil, allowing it to effectively treat OCD as well.
“The clearance of BrainsWay’s OCD device marks a historic milestone in the treatment of this neurological disorder,” said Dr. Joseph Zohar, a professor of psychiatry at the Sackler Faculty of Medicine at Tel Aviv University. “This is a new groundbreaking treatment option for patients looking for a meaningful and potentially life-changing solution for OCD.”
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