Nexstim announces FDA clearance for NexSpeech® – enabling noninvasive speech mapping prior to neurosurgery

Helsinki, Finland: 11 June 2012 - 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.

More info on the press release or on Nexstim's website.