Clearmind Biomedical announced today that it received FDA 510(k) clearance for its Neuroblade neuroendoscopy system.

Clearmind Biomedical今天宣布，其Neuroblade神经内镜系统获得FDA 510（k）许可。

The novel system enables minimally invasive procedures with integrated features such as visualization, illumination, irrigation, suction, coagulation, and powered debridement. San Jose, California-based Clearmind also announced the first completed U.S. surgery using Neuroblade. Dr. Christopher Kellner performed the procedure at Mt.

该新型系统可实现具有可视化，照明，冲洗，抽吸，凝血和动力清创等综合功能的微创手术。总部位于加利福尼亚州圣何塞的Clearmind还宣布了美国第一次使用Neuroblade完成的手术。克里斯托弗·凯尔纳博士在Mt进行了手术。

Neuroblade features three components. First, it has a single-use multifunctional endoscope, called the Neuroblade. Next, it features Neuropad, a reusable, medical-grade tablet. Clearpath, the third component, is a disposable, transparent access sheath. Clearmind designed the system to improve the efficiency and outcomes of minimally invasive neurosurgical procedures..

Neuroblade具有三个组件。首先，它有一个单次使用的多功能内窥镜，称为神经刀片。接下来，它的特点是欧米诺，一种可重复使用的医用级平板电脑。Clearpath是第三个组件，是一个一次性的透明进入护套。Clearmind设计该系统是为了提高微创神经外科手术的效率和结果。。

In the initial Neuroblade case, Dr. Kellner used Neuroblade during an urgent procedure to evacuate a hemorrhagic stroke. Clearpath allowed precise access to the target area and Neuroblade provided an all-in-one instrument with real-time visualization and integrated tools.

在最初的Neuroblade病例中，Kellner博士在紧急手术中使用Neuroblade撤离出血性中风。Clearpath允许精确访问目标区域，Neuroblade提供了一个具有实时可视化和集成工具的一体化仪器。

Kellner called Neuroblade a “valuable new tool” for managing intracerebral hemorrhage. The doctor said its minimally invasive design streamlines the operating room setup and potentially improves outcomes. Kellner believes it could simplify neurosurgical procedures.

。这位医生说，它的微创设计简化了手术室的设置，并有可能改善结果。Kellner认为它可以简化神经外科手术。

“FDA clearance and the first U.S. surgery mark significant milestones for the Neuroblade System, which we believe will revolutionize minimally invasive neurosurgery,” said J. Dustin Duckett, Clearmind Biomedical VP and GM for the Americas. “Developed with input from surgeons, Neuroblade’s integrated features aim to enhance surgical efficiency and patient outcomes.

Clearmind Biomedical副总裁兼美洲总经理J.Dustin Duckett说：“FDA的批准和美国的第一次手术标志着Neuroblade系统的重要里程碑，我们相信这将彻底改变微创神经外科手术。”。“Neuroblade的综合功能是根据外科医生的意见开发的，旨在提高手术效率和患者预后。

We look forward to further developing evidence, driving adoption, and ultimately getting more patients access to desperately needed care.”.

我们期待着进一步开发证据，推动采用，并最终使更多患者获得急需的护理。”。