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奥林巴斯宣布其最先进的成像内窥镜获得FDA批准

Olympus Announces FDA Clearance of Its Most Advanced Imaging Endoscopes

CISION 等信源发布 2025-05-28 02:08

可切换为仅中文


/PRNewswire/ -- Olympus, a global medical technology company committed to making people's lives healthier, safer and more fulfilling, announced today FDA 510(k) clearance of its EZ1500 series endoscopes featuring Extended Depth of Field (EDOF™) technology.

/PRNewswire/ -- 全球医疗技术公司奥林巴斯(Olympus)致力于让人们的生活更健康、更安全、更充实,今天宣布其EZ1500系列内窥镜获得FDA 510(k)许可,该系列采用扩展景深(EDOF™)技术。

Olympus announces FDA 510(k) clearance of its EZ1500 series endoscopes featuring Extended Depth of Field (EDOF™) technology as part of the EVIS X1™ endoscopy system

奥林巴斯宣布其EZ1500系列内窥镜获得FDA 510(k)许可,该系列内窥镜采用扩展景深(EDOF™)技术,是EVIS X1™内窥镜系统的一部分。

EDOF™ endoscopes – the GIF-EZ1500 gastroscope and the CF-EZ1500DL/I colonoscope –  represent Olympus' most advanced imaging and latest innovation as part of the EVIS X1™ endoscopy system. By allowing physicians to obtain sharp images, EDOF technology allows an entire lesion to be kept in focus and may aid in detection as endoscopists inspect the mucosal lining of the GI tract..

EDOF™ 内窥镜——GIF-EZ1500 胃镜和 CF-EZ1500DL/I 结肠镜——代表了奥林巴斯在 EVIS X1™ 内窥镜系统中最新进的成像技术与创新。通过让医生获取清晰图像,EDOF 技术能够使整个病灶保持对焦,并可能在内镜医师检查胃肠道黏膜时辅助检测。

EDOF technology creates an image in total focus by using two prisms to split light entering the endoscope lens into two separate beams with near- and far-focused images. Those beams are then projected simultaneously onto an image sensor, combining them into one image with a wide depth of field.

EDOF技术通过使用两个棱镜将进入内窥镜镜头的光线分成两束分别聚焦于近处和远处的光束,从而创建一个全焦点的图像。然后这些光束同时投射到图像传感器上,将它们合并成一个具有大景深的图像。

Compared to the previous generation of Olympus® scopes, this technology provides improved visibility and less blurring. The EZ1500 series EDOF scopes allow for closer distance in normal mode compared to the CF-HQ190L/I – 3mm vs. 5mm – without blurring, limiting the need to switch from normal to near mode..

与上一代奥林巴斯®内窥镜相比,该技术提供了更好的可见性和更少的模糊。EZ1500系列EDOF内窥镜在正常模式下比CF-HQ190L/I允许更近的距离——3毫米对比5毫米——且没有模糊,减少了从正常模式切换到近距模式的需求。

The GIF-EZ1500 gastroscope and the CF-EZ1500DL/I colonoscope also feature a lightweight ErgoGrip™ control section and compatibility with Texture and Color Enhancement Imaging (TXI™), Red Dichromatic Imaging (RDI™) and Narrow Band Imaging™ (NBI™) technologies when connected to the EVIS X1 CV-1500 video system center..

GIF-EZ1500胃镜和CF-EZ1500DL/I结肠镜还具有轻量化的ErgoGrip™控制部分,并且在连接到EVIS X1 CV-1500视频系统中心时,兼容纹理和色彩增强成像(TXI™)、红二色成像(RDI™)以及窄带成像(NBI™)技术。

The ErgoGrip™ control section of EVIS X1 endoscopes is 10% lighter than the 190 series scope control section and features a rounded handle and easy-to-reach angulation control knobs and switches to accommodate users with small hands and support scope maneuverability.

EVIS X1内窥镜的ErgoGrip™控制部分比190系列内窥镜的控制部分轻10%,并配有圆形手柄和易于触及的角度控制旋钮及开关,适合手掌较小的使用者并提高内窥镜的操控性。

'As a leading global MedTech company, Olympus remains committed to providing advanced options to help physicians offer their patients the best care possible,' said

“作为全球领先的医疗技术公司,奥林巴斯始终致力于提供先进的选择,帮助医生为患者提供最好的护理,”

Kurt Heine

库尔特·海内

, Senior Vice President and General Manager for Gastrointestinal Solutions at Olympus Corporation. 'Our goal is to elevate the standard of endoscopy, and Extended Depth of Field (EDOF) technology represents Olympus' most advanced scope technology to help physicians drive the best clinical outcomes for advancing gastrointestinal procedures.'.

奥林巴斯公司胃肠解决方案高级副总裁兼总经理表示:“我们的目标是提升内窥镜的标准,而扩展景深(EDOF)技术代表了奥林巴斯最先进的内窥镜技术,有助于医生在推进胃肠手术方面取得最佳临床效果。”

The EVIS X1™ endoscopy system revolutionizes the way gastrointestinal disorders are detected, characterized and treated with innovative, easy-to-use diagnostic and therapeutic technologies and improved scope handling. The EVIS X1 endoscopy system provides a high level of patient care for every endoscopist, in every procedure, every day..

EVIS X1™ 内窥镜系统通过创新的、易于使用的诊断和治疗技术以及改进的镜体操作,革新了胃肠道疾病检测、特征分析和治疗方法。EVIS X1 内窥镜系统为每位内窥镜医生在每次手术中、每一天都提供了高水平的患者护理。

In addition to the newest EDOF technology, features of the EVIS X1 endoscopy system include:

除了最新的EDOF技术外,EVIS X1内窥镜系统的功能还包括:

TXI™ technology, which is designed to increase the visibility of lesions and polyps by enhancing image color and texture.

TXI™ 技术,旨在通过增强图像颜色和纹理来提高病灶和息肉的可见性。

RDI™ technology, which is designed to enhance the visibility of deep blood vessels and bleeding points.

RDI™ 技术,旨在增强深部血管和出血点的可见性。

NBI™ technology, which enhances visual observation of mucosal and vascular patterns by utilizing specific blue and green wavelengths absorbed by hemoglobin.

NBI™技术,利用血红蛋白吸收的特定蓝光和绿光波长,增强对粘膜和血管模式的视觉观察。

Brightness Adjustment Imaging with Maintenance of Contrast (BAI-MAC™) technology, which is designed to correct the brightness levels in dark areas of the endoscopic image, while maintaining the brightness of lighter areas, to increase the total distance view.

亮度调整成像与对比度维持(BAI-MAC™)技术,旨在校正内窥镜图像暗区的亮度水平,同时保持亮区的亮度,以增加总可视距离。

TXI, RDI, BAI-MAC and NBI technologies are not intended to replace histopathological sampling as a means of diagnosis. These are adjunctive tools for endoscopic examination that can be used to supplement Olympus® white light imaging.

TXI、RDI、BAI-MAC 和 NBI 技术并非旨在取代组织病理学取样作为诊断手段。这些是内镜检查的辅助工具,可以用来补充奥林巴斯®白光成像。

About Olympus

奥林巴斯简介

At Olympus, we are committed to Our Purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states..

在奥林巴斯,我们致力于实现让人们的健康、安全和生活更加充实的宗旨。作为一家全球医疗技术公司,我们与医疗专业人员合作,提供早期检测、诊断和微创治疗的解决方案和服务,旨在通过提升目标疾病状态的护理标准来改善患者的治疗效果。