FDA批准了Mendaera的机器人系统用于超声引导下的针头放置-动脉网

FDA clears Mendaera’s robotic system for ultrasound-guided needle placement

Medical Device Network 等信源发布 2025-07-09 08:45

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The system combines real-time imaging with a handheld robotic control to assist clinicians in performing a wide range of minimally invasive procedures and settings. Credit: PeopleImages.com – Yuri A / Shutterstock.

该系统结合了实时成像和手持机器人控制，协助临床医生执行各种微创手术和设置。图片来源：PeopleImages.com – Yuri A / Shutterstock.

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Mendaera’s Focalist, a handheld robotic system designed to improve the precision of ultrasound-guided needle placement.

美国食品药品监督管理局 (FDA) 已授予 Mendaera 的 Focalist 510(k) 许可，这是一种旨在提高超声引导下针头放置精度的手持式机器人系统。

According to the company, the system combines real-time imaging with a handheld robotic control to assist clinicians in performing a wide range of minimally invasive procedures and settings.

据该公司介绍，该系统将实时成像与手持机器人控制相结合，协助临床医生执行各种微创手术和设置。

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Its features include robotic needle positioning, touchscreen targeting, and continuous needle depth-tracking.

其特点包括机器人针头定位、触摸屏瞄准和连续的针头深度跟踪。

With the FDA clearance now secured, the company is planning a limited launch of the system in select medical institutions throughout the year, initially targeting the field of urology.

随着FDA的批准现已获得，公司计划在今年内于选定的医疗机构中有限度地推出该系统，最初目标领域是泌尿科。

The system is said to support procedures such as percutaneous nephrolithotomy (PCNL), which requires precise kidney access.

该系统据说可以支持诸如经皮肾镜取石术 (PCNL) 等需要精确肾脏通路的手术。

The full commercialisation of the system is expected to take place in 2026.

该系统的全面商业化预计将于2026年实现。

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Focalist received clearance for use in adult and paediatric patients for guiding the placement of interventional devices relative to the ultrasound transducer to aid in diagnostic or therapeutic procedures.

Focalist 已获准用于成人和儿科患者，以引导介入设备相对于超声探头的放置，辅助诊断或治疗程序。

Mendaera CEO and co-founder Josh DeFonzo said: “Precise placement of needles to perform a wide range of procedures — organ access, biopsies, vascular access, or therapy delivery, as examples — is a very challenging, but foundational technique that underpins most patient care journeys.

曼达拉首席执行官兼联合创始人乔什·德方佐表示：“精确放置针头以执行各种程序——例如器官通路、活检、血管通路或治疗递送——是一项非常具有挑战性但基础性的技术，是大多数患者护理过程的关键所在。”

“Our mission is to ensure that these procedures are delivered safely and efficiently across the healthcare system by enabling more providers with the confidence needed to perform these techniques. Robotics have been shown to increase provider capabilities in complex procedures, and we intend to demonstrate that the same can be true in everyday care.”.

“我们的使命是确保这些程序能够通过让更多的医疗服务提供者具备执行这些技术的信心，从而在医疗系统中安全高效地实施。机器人技术已经证明可以提升复杂手术中医护人员的能力，我们打算证明其在日常护理中同样有效。”

Last year, Mendaera

去年，门德拉

raised $73m to progress

筹集了7300万美元以推进

its handheld needle-based robot technology into areas of surgery such as biopsies, organ and vascular access, as well as pain management interventions.

其手持式基于针头的机器人技术应用于手术领域，如活检、器官和血管通路，以及疼痛管理干预。

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