FDA clears Nexstim’s new module for use with NBS System

Nexstim Oy, a medical device company, announced today that the U.S. Food and Drug Administration (FDA) has cleared the NexSpeech^® module for use with the Navigated Brain Stimulation (NBS) System. In presurgical planning for patients with brain tumors, the NBS System enables accurate and reliable mapping of the vital motor areas in the brain. Now, with NexSpeech, cortical areas that do not contain essential speech function can also be localized.

Neurosurgeons have long awaited accurate and reliable noninvasive tools for pre-operative planning. Previously, the only reliable techniques were invasive and required craniotomy. NBS is a major advance for tailoring neurosurgical treatment to the needs of the individual patient with a brain tumor. Information from NBS with NexSpeech may help lower the risk of damage to eloquent cortex, as well as help shorten operating times. Importantly, using NBS with NexSpeech potentially allows more patients with brain tumors to benefit from surgery.

With NexSpeech, the NBS System uses navigated repetitive transcranial magnetic stimulation (rTMS) to temporarily disrupt cortical areas essential for speech. While the patient names everyday images, a coil is gently moved over the head and used to give synchronized bursts of stimuli. Analysis of patient's speech behavior results in a map of cortical areas vital for speech, displayed in the patient's MRI.