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放射肿瘤治疗和软件制造商Varian宣布采用HyperSight成像解决方案的TrueBeam和Edge放射治疗系统获得FDA 510(k)许可

Varian Receives FDA 510(k) Clearance for TrueBeam and Edge Radiotherapy Systems Featuring HyperSight Imaging Solution

CISION | 2024-02-29 | 翻译由动脉网AI生成,点击反馈

可切换为仅中文


PALO ALTO, Calif., Feb. 29, 2024 /PRNewswire/ -- Varian, a Siemens Healthineers company, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for TrueBeam and Edge radiotherapy systems featuring HyperSight imaging solution. By extending the groundbreaking HyperSight imaging solution optional feature to the TrueBeam and Edge systems, Varian continues to revolutionize imaging inside the radiotherapy treatment room and adds new capabilities and workflows across the entire suite of linear accelerators.

2024年2月29日,加利福尼亚州帕洛阿尔托(PALO ALTO),西门子Healthineers公司瓦里安(Varian)宣布,该公司已获得美国食品和药物管理局(FDA)510(k)的许可,可用于使用HyperSight成像解决方案的TrueBeam和Edge放射治疗系统。通过将开创性的HyperSight成像解决方案可选功能扩展到TrueBeam和Edge系统,Varian继续革新放射治疗室内的成像,并在整个线性加速器套件中添加新功能和工作流程。

HyperSight empowers clinicians to accurately tailor treatments to each individual patient with the goal of improving patient outcomes.

HyperSight使临床医生能够准确地为每位患者量身定制治疗方法,以改善患者预后。

HyperSight imaging allows clinicians to acquire high-quality images during a patient's daily course of radiation treatments. The enhanced image quality is designed to improve the ability to target tumor volumes more precisely and spare healthy tissue for patients receiving radiation therapy treatments.

HyperSight成像允许临床医生在患者的日常放射治疗过程中获得高质量的图像。增强的图像质量旨在提高更精确地靶向肿瘤体积的能力,并为接受放射治疗的患者保留健康组织。

With the addition of HyperSight, linear accelerators across the Varian portfolio can now produce images that deliver the Hounsfield Unit (HU) accuracy necessary for treatment planning directly on the acquired conebeam CT (CBCT) images. As a result, this technology can be used for offline adaptive planning to adjust for anatomical changes to the tumor and surrounding organs over the course of treatment without the need for an additional trip to a separate CT scanner.

随着HyperSight的加入,瓦里安投资组合中的线性加速器现在可以产生图像,直接在采集的conebeam CT(CBCT)图像上提供治疗计划所需的Hounsfield单位(HU)精度。因此,该技术可用于离线自适应计划,以调整治疗过程中肿瘤和周围器官的解剖变化,而无需额外前往单独的CT扫描仪。

HyperSight on TrueBeam and Edge acquires images for all anatomical sites with a 50% faster gantry rotation, significantly reducing acquisition time. In contrast, traditional CBCT scans can take up to 60 seconds, depending on the anatomical site being scanned. A reduction in CBCT acquisition time reduces motion-related artifacts due to patient movement.

TrueBeam和Edge上的HyperSight以50%的速度获取所有解剖部位的图像,从而大大缩短了采集时间。相比之下,传统的CBCT扫描可能需要60秒,具体取决于扫描的解剖部位。CBCT采集时间的减少减少了由于患者运动引起的运动相关伪影。

A shorter image acquisition time may minimize patient discomfort and anxiety due to less time on the treatment table.

较短的图像采集时间可以最大程度地减少患者的不适和焦虑,因为治疗台上的时间较少。

The Cancer Institute at Northwell Lenox Hill in New York was one of the early adopters of HyperSight imaging on their Halcyon system. 'HyperSight imaging has allowed us to improve patient comfort by decreasing the time patients spend on the treatment table while simultaneously targeting with greater confidence,' said Dr.

纽约Northwell Lenox Hill的癌症研究所是Halcyon系统超视距成像的早期采用者之一HyperSight成像通过减少患者在治疗台上花费的时间,同时更有信心地瞄准患者,使我们能够提高患者的舒适度。

Wesley Talcott, Assistant Professor and Radiation Oncologist, Department of Radiation Medicine at Lenox Hill Hospital. 'We look forward to further streamlining care for our patients using HyperSight.'

莱诺克斯山医院放射医学系助理教授兼放射肿瘤学家韦斯利·塔尔科特说我们期待着使用HyperSight进一步简化对患者的护理。”

Initially launched in 2022 on Varian's Ethos and Halcyon therapy systems, HyperSight has been gaining popularity among clinicians and researchers alike. With nine studies either conducted, in progress, or to be initiated across eight institutions, Varian is committed to better understanding the role HyperSight may play in advancing care and enhancing the patient experience.

最初于2022年在瓦里安的Ethos和Halcyon治疗系统上推出,HyperSight在临床医生和研究人员中越来越受欢迎。瓦里安致力于更好地了解超视力在推进护理和增强患者体验方面可能发挥的作用,目前正在八家机构进行、正在进行或即将启动九项研究。

The customer-led Intelligent Imaging Consortium, created by Varian, offers HyperSight users a forum to collaborate and innovate on trials and studies.

由瓦里安创建的以客户为主导的智能成像联盟为HyperSight用户提供了一个在试验和研究中进行合作和创新的论坛。

'As a Siemens Healthineers company, we are pioneering innovative solutions to advance radiotherapy and connect the power of imaging, both inside and outside the treatment room,' said Arthur Kaindl, Head of Varian. 'We are excited to expand HyperSight imaging technology to our TrueBeam and Edge platforms and further collaborate with our clinical partners to provide an integrated portfolio that connects the dots along the cancer care continuum.'

瓦里安公司负责人亚瑟·坎德尔(ArthurKaindl)说:“作为西门子Healthineers公司,我们正在开创创新解决方案,以推进放射治疗,并在治疗室内外连接成像功能。”我们很高兴将HyperSight成像技术扩展到我们的TrueBeam和Edge平台,并与我们的临床合作伙伴进一步合作,提供一个集成的组合,将癌症护理连续体中的各个点连接起来。”

The statement by Varian's customer described above is based on results achieved in the customer's unique clinical setting. Because there is no 'typical' clinical setting and many variables exist, there is no guarantee that other customers will achieve the same results.

上述瓦里安客户的声明是基于在客户独特的临床环境中取得的结果。由于没有“典型”的临床环境,并且存在许多变量,因此无法保证其他客户会获得相同的结果。

VARIAN, TRUEBEAM, EDGE, ETHOS, HALCYON, HYPERSIGHT are trademarks of Varian Medical Systems, Inc., pending or registered U.S. Pat. & Tm. Off.

VARIAN、TRUEBEAM、EDGE、ETHOS、HALCYON、HYPERSIGHT是VARIAN Medical Systems,Inc.的商标,正在申请或注册美国专利Tm关闭。

About VarianAt Varian, a Siemens Healthineers company, we envision a world without fear of cancer. For more than 75 years, Varian has developed, built, and delivered innovative technologies and solutions that help care providers around the globe treat millions of patients each year. Today, as a Siemens Healthineers company, we support every step of the cancer care journey – from screening to survivorship.

关于西门子Healthineers公司VarianAt Varian,我们设想一个没有癌症恐惧的世界。75多年来,瓦里安开发、制造并提供了创新技术和解决方案,帮助全球护理提供者每年治疗数百万患者。今天,作为西门子Healthineers公司,我们支持癌症护理旅程的每一步,从筛查到生存。

From advanced imaging and radiation therapy, to comprehensive software and services, to interventional radiology, we are harnessing the power of our perspective while also pursuing clinical research to create a more efficient, and more personalized care pathway. Because, for cancer patients everywhere, their fight is our fight.

从先进的成像和放射治疗,到全面的软件和服务,再到介入放射学,我们正在利用我们的观点的力量,同时也在进行临床研究,以创建更高效,更个性化的护理途径。因为,对于世界各地的癌症患者来说,他们的斗争就是我们的斗争。

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