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介入放射学公司Medical Templates宣布Cube Navigator软件获FDA批准,用于规划经皮CT引导干预

Zurich Medtech startup gets FDA clearance

startupticker | 2024-04-09 | 翻译由动脉网AI生成,点击反馈

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Medical Templates, the startup innovating the interventional radiology space, announced the receipt of the U.S. FDA clearance for its Cube Navigator software for planning of percutaneous, CT-guided interventions.

创新介入放射学空间的初创公司Medical Templates宣布,其Cube Navigator软件已获得美国食品和药物管理局(FDA)的批准,用于规划经皮CT引导的干预措施。

Navigation is gaining importance in the field of interventional radiology, mainly driven by expanding treatment options in oncology and improved patient outcomes through the use of minimally-invasive procedures.   Smaller targets, more complex access routes, and time and personnel constraints have all contributed to the increased adoption of CT navigation systems..

导航在介入放射学领域越来越重要,主要是由于扩大了肿瘤学的治疗选择,并通过使用微创手术改善了患者的预后。较小的目标,更复杂的访问路线,以及时间和人员限制都有助于CT导航系统的采用。。

Medical templates, founded in 2017, is bringing intuitive, simple solutions in radiology and minimally invasive CT-guided interventions to market. Its Cube Navigation System (CNS) comprises a computer vision-enabled software that pairs with its proprietary hardware – a needle guide in the form of a Cube – as an alternative to free-hand navigation as well as capital-intensive solutions such as robots..

成立于2017年的Medical templates正在将放射学和微创CT引导干预的直观,简单的解决方案推向市场。其立方体导航系统(CNS)包括一个支持计算机视觉的软件,该软件与专有硬件(立方体形式的针导)配对,作为徒手导航以及机器人等资本密集型解决方案的替代方案。。

“Market pressures are pushing physicians to perform increasingly complex procedures, while reimbursement continues to be a driving force in determining which tools are used during interventions.  The Cube Navigation System was designed to provide accurate navigation at a reasonable price point, without compromising on workflow complexity or speed,” says CEO Anika Uhde.  “Centers in Europe have been enthusiastic about our solution because of its ease of use and incredibly fast onboarding.

“市场压力迫使医生执行越来越复杂的程序,而报销仍然是决定干预过程中使用哪些工具的驱动力。多维数据集导航系统旨在以合理的价格提供准确的导航,而不会影响工作流程的复杂性或速度,”首席执行官安妮卡·乌德(Anika Uhde)说。“欧洲的中心一直对我们的解决方案充满热情,因为它易于使用,而且上线速度非常快。

They see an improvement almost immediately.”.

他们几乎立即看到了改善。”。

A recent study published in the Journal of Vascular and Interventional Radiology (JVIR) found that punctures performed with the Cube Navigation System were more than 4x closer to the target on the initial puncture (2.5 mm ± 1.2 mm vs. FHM 12.1 mm ± 7.7 mm), had significantly more accurate final needle locations (3.8 mm ± 1.3 mm vs.

最近发表在《血管与介入放射学杂志》(JVIR)上的一项研究发现,使用立方体导航系统进行的穿刺在初始穿刺时距离目标近4倍以上(2.5 mm±1.2 mm vs.FHM 12.1 mm±7.7 mm),最终针头位置显着更准确(3.8 mm±1.3 mm vs。

FHM 6.7 mm ± 4.5 mm, p=0.004), and were significantly faster (263.1 s ± 84.4 s vs. FHM 411.2 s ± 141.0 s, p<0.001).  Further studies on accuracy and speed are currently being carried out in Switzerland and Germany..

FHM 6.7 mm±4.5 mm,p=0.004),速度明显更快(263.1 s±84.4 s vs.FHM 411.2 s±141.0 s,p<0.001)。瑞士和德国目前正在进一步研究准确性和速度。。

Parallel to the ongoing developments, the company's Cube Navigator software has been cleared by the US Food and Drug administration (FDA), cementing the company’s entry and launch in the U.S. market. 

在不断发展的同时,该公司的Cube Navigator软件已获得美国食品和药物管理局(FDA)的批准,巩固了该公司在美国市场的进入和推出。

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