VISTA, Calif., April 29, 2024 /PRNewswire/ -- Leica Biosystems is pleased to announce that its flagship digital pathology system, Aperio GT 450 DX, has received 510(k) clearance from the US Food and Drug Administration. Previously sold into the clinical market under an enforcement discretion due to the COVID-19 pandemic, Aperio GT 450 is proven technology that consistently delivers high-quality images at a fast turnaround time of < 32 sec/slide..

加利福尼亚州维斯塔，2024年4月29日/新闻专线/--徕卡生物系统公司很高兴地宣布，其旗舰数字病理系统Aperio GT 450 DX已获得美国食品和药物管理局510（k）的许可。Aperio GT 450以前因新型冠状病毒肺炎大流行而被强制销售到临床市场，它是一种经过验证的技术，能够以小于32秒/张的快速周转时间始终如一地提供高质量的图像。。

FDA cleared Aperio GT 450 DX solution from Leica Biosystems

FDA批准Leica Biosystems的Aperio GT 450 DX溶液

Aperio GT 450 DX is not Leica Biosystems first regulated system: the company has 25 years of experience implementing, integrating, and innovating in the digital pathology space, enabling clinicians to advance their cancer diagnoses and improve lives.

Aperio GT 450 DX不是Leica Biosystems的第一个监管系统：该公司在数字病理学领域拥有25年的实施，整合和创新经验，使临床医生能够推进癌症诊断并改善生活。

'Digital pathology is rapidly emerging as the cornerstone of modern healthcare, revolutionizing the field of pathology as laboratories across the globe embrace this transformative technology,' said Dr. Sony Wirio, Regional Chief Pathologist and Director of Pathology Informatics at Kaiser Permanente, Southern California.

南加州凯撒永久医院（KaiserPermanente）区域首席病理学家兼病理信息学主任索尼·维里奥（Sony Wirio）博士说：“数字病理学正在迅速成为现代医疗保健的基石，随着全球实验室采用这种变革性技术，病理学领域发生了革命性的变化。”。

'Drawing from our extensive experience in implementing digital pathology within our group of over 100 pathologists, we are excited to be a part of this groundbreaking shift that is shaping digital diagnostics and enhancing patient outcomes.'.

“凭借我们在100多名病理学家团队中实施数字病理学的丰富经验，我们很高兴成为这一开创性转变的一部分，这一转变正在塑造数字诊断并提高患者预后。”。

'There is no better time for laboratories to optimize their workflow with digital,' said Naveen Chandra, Vice President and General Manager of Digital Pathology at Leica Biosystems. 'Today, clinicians are faced with having to do more with less – digital pathology enables them to maintain a high standard of quality with world class images and a fast turnaround time, for the best patient care possible.'About Leica Biosystems:Leica Biosystems is a cancer diagnostics company and a global leader in workflow solutions.

徕卡生物系统公司（LeicaBiosystems）数字病理学副总裁兼总经理纳文钱德拉（NaveenChandra）说，实验室利用数字优化工作流程的最佳时机已经到来如今，临床医生面临着用更少的时间做更多的事情——数字病理学使他们能够通过世界级的图像和快速的周转时间保持高标准的质量，从而尽可能地为患者提供最佳护理。”关于徕卡生物系统：徕卡生物系统是一家癌症诊断公司，也是工作流解决方案的全球领导者。

The company offers a comprehensive product range for each step in the pathology process, from sample preparation and staining to imaging and reporting. As the only company to own the full workflow from biopsy to diagnosis, Leica Biosystems is uniquely positioned to break down the barriers between each step.

该公司为病理过程的每个步骤提供全面的产品范围，从样品制备和染色到成像和报告。作为唯一拥有从活检到诊断的完整工作流程的公司，Leica Biosystems具有独特的地位，可以打破每一步之间的障碍。

The company's mission of 'Advancing Cancer Diagnostics, Improving Lives' is at the heart of its corporate culture.Media Contact:Lauren Meinhardt657-226-6970lauren.meinhardt@leicabiosystems.com  SOURCE Leica Biosystems.

该公司“推进癌症诊断，改善生活”的使命是其企业文化的核心。媒体联系人：LaurenMeinhardt657-226-6970lauren.meinhardt@leicabiosystems.com来源Leica Biosystems。