The Helsinki-based company had expected stroke rehabilitation to be the first FDA-cleared indication for its Navigated Brain Therapy system, but while more data is collected for that program, it is pursuing a 510(k) clearance for NBS to treat major depressive disorder and plans to build a US salesforce to market NBS for therapeutic indications.
Nexstim PLC has filed a 510(k) to US FDA for its NBT (Navigated Brain Therapy) transcranial magnetic stimulation (TMS) therapy system to be cleared for treating major depressive disorder.
Major depressive disorder is a chronic condition affecting 2%-5% of the population in developed countries. Current therapies, based on drugs...