Cyberkinetics公司的神经系统监测产品获得上市许可

一种记录和监测脑部电活动新型神经监测系统被设计用于急性监护患者：例如严重癫痫接受选择性外科手术治疗的患者，脑卒中和脑损伤接受颅骨切开手术的患者。这套系统已经获得了美国食品药品管理局的许可。

这套系统包括NeuroPort脑皮质层微电极检测（NeuroPort检测）以及NeuroPort神经信号处理器（NeuroPort NSP）。NeuroPort系统为神经科医生和神经外科医生提供了一种检测、传播以及分析接受颅骨切开手术患者的神经活动的新方法。这种检测方法可以从大脑皮质层收集综合的或者单个的神经信号。NSP可以记录这些信号，医生通过分析这些信号，将其做为诊断与治疗神经系统疾病的一部分。

研制开发这套系统的Cyberkinetics神经技术系统公司的总裁兼首席执行官Timothy R.Surgenor说：“NeuroPort系统是我们首个商业化的临床产品，其获得上市许可，是我们公司开发用于诊断、检测和治疗神经系统疾病和损伤产品战略极其重要的第一步。NeuroPort检测和NeuroPort SNP是来自我们BrainGate神经界面系统的重要组成部分。”
 
Neural Monitoring of Acute Care Patients
 
A new neural system that records and monitors brain electrical activity is designed for patients in acute care, such as patients undergoing elective surgery for the treatment of severe epilepsy and patients undergoing emergency craniotomies for stroke and brain injury. The system has been cleared by the U.S. Food and Drug Administration (FDA).

The system comprises the NeuroPort cortical microelectrode array (NeuroPort array) and the NeuroPort neural signal processor (NeuroPort NSP). The NeuroPort system provides neurologists and neurosurgeons with 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 doctor as a part of the diagnosis and treatment of neurologic conditions.

“Marketing clearance of the NeuroPort system, our first commercial clinical product, is an important first step in our strategy to develop a broad family of products to diagnose, monitor, and treat neurological diseases and injuries,” noted Timothy R. Surgenor, president and CEO of Cyberkinetics Neurotechnology Systems, Inc. (Foxborough, MA, USA), which developed the system. “The NeuroPort array and the NeuroPort SNP are both critical components derived from our BrainGate neural interface system.”