Nexstim's Navigated Brain Stimulation System receives FDA clearance

Nexstim Oy, a medical device company, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Navigated Brain Stimulation System for use in the assessment of the primary motor cortex for pre-procedural planning.

Using transcranial magnetic stimulation (TMS) guided by standard MR-image data, Nexstim has developed Navigated Brain Stimulation (NBS), the first non-invasive direct technique for functional mapping of the motor cortex. In its FDA submission, Nexstim included data comparing the accuracy of NBS pre-operative mapping with the results of “gold standard” direct cortical stimulation during actual brain tumor surgery.

Neurosurgeons have long awaited a reliable, non-invasive, tool for pre-operative planning as an alternative to direct cortical stimulation, an invasive technique which is performed after craniotomy at the beginning of surgery. Cortical mapping with NBS is a major advance that may help in tailoring neurosurgical treatment and planning to the needs of the individual patient - potentially saving valuable time in the OR and helping ensure the best possible outcome for the patient.

Lothar Koob, Chairman of the Board of Nexstim commented, “This first FDA clearance for Nexstim marks an important milestone in the development of the company, and based on very encouraging feedback from clinicians we see many additional potential applications for our proprietary navigated brain stimulation technologies.”