Nexstim Looks To Break Into US TMS Market With Depression Indication
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.
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US FDA used its de novo review pathway to approve Brainsway Ltd.’s Brainsway Deep Transcranial Magnetic Stimulation System to treat obsessive compulsive disorder.
Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions and suspensions each month. News about trials of cardiovascular devices, especially novel heart valve replacement technologies, lead this month's edition, covering mid-May through mid-June.
The registry will collect data from more than 6,000 depression patients treated with transcranial magnetic stimulation at more than 100 different treatment facilities in the US to better understand how the therapy benefits patients in the "real world."