FDA Clears Cyberkinetics' NeuroPort System

Cyberkinetics Neurotechnology Systems has obtained 510(k) clearances for its NeuroPort Cortical Microelectrode Array and NeuroPort Neural Signal Processor (NSP). The devices comprise a neural monitoring system designed for acute inpatient applications, and labeled for temporary -- less than 30 days -- recording and monitoring of brain electrical activity.

The NeuroPort System is capable of providing neurologists and neurosurgeons a new resource to detect, transmit and analyze neural activity of patients who have undergone craniotomy. The array allows the collection of aggregate or individual neural signals from the cortical region of the brain. The NSP allows these signals to be recorded and analyzed by the physician as a part of the diagnosis and treatment of neurological conditions.

Cyberkinetics anticipates a limited market introduction of the NeuroPort System early in 2006, after completing necessary manufacturing upgrades during the remainder of 2005. Cyberkinetics is evaluating distribution strategies to support a broad product launch before the end of 2006.