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The GenesisX surgical robot system. [Image courtesy of Stereotaxis]Stereotaxis (NYSE:STXS) announced that it obtained CE mark in Europe and submitted an FDA 510(k) application for its next-generation surgical robot.
GenesisX手术机器人系统。[图片由StereoAxis提供]StereoAxis(纽约证券交易所:STXS)宣布在欧洲获得CE标志,并为其下一代手术机器人提交了FDA 510(k)申请。
The GenesisX system is the latest iteration of Stereotaxis’ Genesis robotic magnetic navigation (RMN) system. It builds upon the company’s technology while reducing the complexities and barriers to hospital adoption.
GenesisX系统是立体定向的Genesis机器人磁导航(RMN)系统的最新迭代。它以公司的技术为基础,同时减少了医院采用的复杂性和障碍。
Stereotaxis said in a news release that RMN systems require significant preparations within an operating room. That includes structural modifications, installing thousands of pounds of magnetic shielding, floor reinforcement, high electrical power and extensive cabling.
Stereodiaxis在新闻稿中表示,RMN系统需要在手术室内进行大量准备。这包括结构改进、安装数千磅磁屏蔽、地板加固、高功率和广泛布线。
To address this, GenesisX utilizes smaller magnets and incorporates magnetic shielding into its structure. It requires no structural anchoring through the floor and uses standard 120/230V power outlets. A single fiber connects each robot to the system cabinet, which is 80% smaller than the previous generation of Genesis.
。它不需要通过地板进行结构锚固,并使用标准的120/230V电源插座。一根光纤将每个机器人连接到系统机柜,比上一代Genesis小80%。
The system can fit under a table in an operating room and maintains the speed, responsiveness and workflow of Genesis. The company plans to use it as a platform for additional innovations in the future..
该系统可以放在手术室的桌子下,保持Genesis的速度、响应能力和工作流程。该公司计划将其用作未来进一步创新的平台。。
With CE mark obtained and a submission made to the FDA, Stereotaxis plans to use the coming months to achieve further milestones. Those include regulatory approval for compatible catheters, real-world data for the system, enhanced capabilities with X-ray systems and supply chain preparation.
。这些包括对兼容导管的监管批准,系统的真实数据,X射线系统的增强功能和供应链准备。
Stereotaxis hopes for a full launch and significant adoption in 2025.
Stereotaxis希望在2025年全面推出并获得重大采用。
“We are excited to introduce GenesisX and share the achievement of these significant milestones,” said David Fischel, chair and CEO. “The clinical value of Stereotaxis’ robotic technology has been extensively demonstrated yet difficult to access for the vast majority of interested physicians and hospitals.
主席兼首席执行官大卫·菲舍尔(DavidFischel)表示:“我们很高兴能介绍GenesisX,并分享这些重要里程碑的成就。”。“立体定向机器人技术的临床价值已被广泛证明,但绝大多数感兴趣的医生和医院难以获得。
GenesisX is strategically transformative as it supports broad adoption of robotics in electrophysiology and across endovascular interventions.”.
GenesisX具有战略性变革,因为它支持机器人技术在电生理学和血管内干预中的广泛应用。”。