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Microbot Medical完成试验,将于今年向美国食品药品监督管理局提交手术机器人

Microbot Medical completes trial, set to submit surgical robot to FDA this year

MASSDEVICE 等信源发布 2024-10-15 02:26

可切换为仅中文


Liberty surgical robotic system [Image courtesy of Microbot Medical]Microbot Medical (Nasdaq:MBOT) announced today that it successfully completed enrollment and follow-up in its surgical robot clinical trial.

Liberty surgical robot system[图片由Microbot Medical提供]Microbot Medical(纳斯达克:MBOT)今天宣布,它成功完成了手术机器人临床试验的注册和随访。

The Braintree, Massachusetts-based company completed enrollment and follow-up for all patients in the ACCESS-PVI human clinical trial. It now expects to file an FDA 510(k) submission for the Liberty endovascular surgical robot system by the end of 2024.

这家位于马萨诸塞州Braintree的公司完成了ACCESS-PVI人体临床试验中所有患者的登记和随访。它现在希望在2024年底之前提交FDA 510(k)提交的自由血管内手术机器人系统。

Additionally, Microbot announced plans to accelerate its go-to-market strategy in advance of its regulatory submission. It expects to begin building out commercial infrastructure, which includes hiring a seasoned healthcare executive to lead sales efforts. The company earmarked this for when it earns FDA clearance, which it anticipates in the second quarter of 2025..

。它预计将开始建设商业基础设施,其中包括聘请一名经验丰富的医疗保健高管来领导销售工作。该公司预计在2025年第二季度获得FDA批准后,将专门用于此。。

Microbot designed its Liberty surgical robot for potential use in neurovascular, cardiovascular and peripheral vascular procedures. The system includes a compact design and remote operating capabilities to reduce radiation exposure and physical strain on physicians. Microbot believes Liberty’s remote operation could potentially make it the first system to democratize endovascular interventional procedures..

Microbot设计了其Liberty手术机器人,可用于神经血管,心血管和外周血管手术。该系统包括紧凑的设计和远程操作功能,以减少辐射暴露和医生的身体压力。Microbot认为,Liberty的远程操作可能使其成为第一个民主化血管内介入手术的系统。。

“This is a monumental moment and a significant achievement for Microbot Medical,” said Harel Gadot, chair, CEO and president. The conclusion of the trial and physician feedback is an encouraging development, and our immediate task is to prepare and finalize the FDA 510(k) submission package so we can file it by the end of the year.

主席、首席执行官兼总裁哈雷尔·加多(HarelGadot)表示:“这是Microbot Medical的一个里程碑式的时刻,也是一项重大成就。”。试验的结论和医生的反馈是一个令人鼓舞的发展,我们的当务之急是准备和完成FDA 510(k)提交包,以便我们可以在年底之前提交。

Concurrently, we will deploy our go-to-market strategy and begin to build out a commercial infrastructure to ensure we are fully prepared to launch Liberty upon the FDA’s clearance, which we expect during 2Q 2025.”.

同时,我们将部署我们的上市战略,并开始建立商业基础设施,以确保我们做好充分准备,在FDA批准后推出Liberty,我们预计将在2025年第二季度推出。”。