Microbot Medical向美国食品药品监督管理局提交Liberty手术机器人医药_健康_365医药针灸按摩医药_健康_365医药中医中药医药_健康

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Microbot Medical向美国食品药品监督管理局提交Liberty手术机器人 Microbot Medical submits Liberty surgical robot to FDA MASSDEVICE 等信源发布 2024-12-10 22:55 

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Liberty surgical robotic system [Image courtesy of Microbot Medical]Microbot Medical (Nasdaq:MBOT) announced today that it submitted an FDA 510(k) premarket notification for its Liberty surgical robot.

Liberty surgical robot system[图片由Microbot Medical提供]Microbot Medical（纳斯达克：MBOT）今天宣布，它为其Liberty surgical robot提交了FDA 510（k）上市前通知。

Microbot designed its Liberty single-use endovascular 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设计了Liberty一次性血管内手术机器人，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。

Braintree, Massachusetts-based Microbot believes Liberty’s remote operation could potentially make it the first system to democratize endovascular interventional procedures. The company says it’s the world’s first single-use, fully disposable robotic system for those procedures.

。该公司表示，这是世界上第一个用于这些手术的一次性完全一次性机器人系统。

Microbot’s FDA submission follows the completion of a study of Liberty in humans undergoing peripheral vascular interventions this year. The company expects to receive clearance during the second quarter of 2025. It plans to begin U.S. commercialization activities following the regulatory nod.

Microbot提交给FDA之前，今年完成了一项关于接受外周血管介入治疗的人类自由的研究。该公司预计在2025年第二季度获得许可。该公司计划在获得监管批准后开始美国的商业化活动。

In October, the company laid out marketing plans for Liberty. It expects to begin building out commercial infrastructure, which includes hiring a seasoned healthcare executive to lead sales efforts.

10月，该公司为Liberty制定了营销计划。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。

“This is a pivotal milestone for our company, as the 510(k) submission reflects the commencement of our transition to a commercially focused company,” said Harel Gadot, chair, CEO and president. “We are excited to transition our focus towards preparing for our expected U.S. launch in the second quarter of 2025 and targeting the more than 2 million peripheral vascular procedures performed in the U.S.

主席、首席执行官兼总裁哈雷尔·加多特（HarelGadot）表示：“这对我们公司来说是一个关键的里程碑，因为510（k）的提交反映了我们开始向以商业为重点的公司过渡。”。“我们很高兴将重点转移到为2025年第二季度在美国的上市做准备，并针对在美国进行的200多万次外周血管手术。

each year..

每年。。

“Based on feedback from physicians and the medical community, we believe that Liberty is positioned to redefine the peripheral endovascular space by introducing the world’s first commercially available single-use robotic system.”

“根据医生和医学界的反馈，我们相信Liberty将通过引入世界上第一个商用一次性机器人系统来重新定义外围血管内空间。”

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