What You Should Know:

你应该知道的：

–

–

PathAI

病理人工智能

, a global leader in artificial intelligence (AI) and digital pathology solutions, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its digital pathology image management system,

，作为人工智能（AI）和数字病理学解决方案的全球领导者，今天宣布其数字病理图像管理系统已获得美国食品药品监督管理局（FDA）的510(k)许可，

AISight® Dx

AISight® Dx

, for use in primary diagnosis in clinical settings.

，用于临床环境中的初步诊断。

– The FDA clearance builds upon the platform’s initial 510(k) clearance for

– FDA的批准是基于该平台最初的510(k)许可

AISight Dx

AISight Dx

(Novo) in 2022, demonstrating PathAI’s ongoing commitment to innovation and delivering enhanced capabilities.

2022年，PathAI通过（Novo）展示了其对创新和提升能力的持续承诺。

Accelerated Innovation Through Predetermined Change Control Plan

通过预定的变更控制计划加速创新

The FDA’s decision also included a Predetermined Change Control Plan (PCCP). This critical regulatory alignment allows PathAI to validate and implement specified major changes, such as additional displays, scanners, file formats, and browsers, into AISight Dx without requiring further 510(k) submissions.

FDA的决定中还包括一份预定变更控制计划（PCCP）。这一关键的监管协调使得PathAI能够在无需进一步提交510(k)文件的情况下，验证并将特定的重大变更（如新增显示功能、扫描仪、文件格式和浏览器）整合到AISight Dx中。

The approach is expected to accelerate future software updates and hardware integrations, enabling faster innovation while ensuring continued FDA compliance..

这种方法有望加速未来的软件更新和硬件集成，在确保持续符合FDA规定的同时实现更快的创新。

Maximizing Efficiency in Anatomic Pathology Workflows

最大化解剖病理学工作流程的效率

AISight Dx is a cloud-native digital pathology platform meticulously designed to maximize efficiency in anatomic pathology workflows. The system offers a comprehensive suite of features, including intelligent case management, high-performance slide review, and seamless live collaboration. These capabilities help laboratories accelerate turnaround times and optimize pathologist productivity..

AISight Dx 是一个云原生的数字病理学平台，精心设计以最大化解剖病理工作流程的效率。该系统提供了一整套综合功能，包括智能病例管理、高性能切片审查和无缝实时协作。这些功能帮助实验室加快周转时间并优化病理学家的工作效率。

With integrated image management, synchronized multi-slide navigation, and robust annotation tools, AISight Dx aims to eliminate manual bottlenecks and support faster, more consistent diagnoses. The platform is built for interoperability, compliance, and scale, empowering anatomic pathology labs, hospital systems, and academic medical centers to modernize their operations and confidently deliver high-quality patient care..

通过集成的图像管理、同步的多幻灯片导航和强大的注释工具，AISight Dx 旨在消除手动瓶颈，支持更快速、更一致的诊断。该平台旨在实现互操作性、合规性和可扩展性，助力解剖病理学实验室、医院系统和学术医疗中心现代化其运营，并自信地提供高质量的患者护理。

“Digital pathology is the future of diagnostic medicine, empowering pathologists to work more efficiently and collaborate quickly without being limited to physical specimen review,” said Andy Beck, M.D., Ph.D., CEO of PathAI. “

“数字病理学是诊断医学的未来，它使病理学家能够更高效地工作，并快速协作，而不受实体标本审查的限制，”PathAI 首席执行官 Andy Beck 医学博士表示。