BrainsWay Gets FDA Ok for H7 Coil in Treatment of Depression

BrainsWay says it has received 510(k) clearance from the FDA for Deep TMS H7 Coil in treating adults suffering from major depressive disorder and anxious depression.

• Clearance was based on review of results from a randomized, double-blind, controlled multicenter trial designed to better understand the H7 Coil’s efficacy in addressing treatment-resistant depression
• Study found overall efficacy rates for the H7 Coil which were comparable to those achieved with BrainsWay’s H1 Coil
• Deep TMS H7 Coil, which has been cleared to treat obsessive-compulsive disorder can now be put to use against depression

NOTE

• Brainsway Ltd. rose 1.8% to ILs753.10 as of ...