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Modella AI

AI 模型

, a pioneer in generative and agentic artificial intelligence for biomedicine, is proud to announce that its cutting-edge generative AI co-pilot,

作为生物医学生成和代理人工智能的先驱，公司自豪地宣布，其尖端的生成人工智能联合试点，

PathChat

PathChat 的

DX, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This recognition underscores PathChat DX’s potential to transform diagnostic workflows and improve patient outcomes in pathology.

DX已被美国食品和药物管理局（FDA）授予突破性的设备名称。这种认识强调了PathChat DX在改变诊断工作流程和改善患者病理结果方面的潜力。

The FDA’s Breakthrough Device Designation is reserved for medical devices that offer significant advantages over existing standards of care, addressing unmet medical needs or providing critical advancements in healthcare. PathChat DX, which is an extension of the PathChat model recently published in .

美国食品和药物管理局（FDA）的突破性设备名称保留给那些比现有护理标准具有显着优势的医疗设备，以解决未满足的医疗需求或提供医疗保健方面的关键进步。PathChat DX是最近发布的PathChat模型的扩展。

Nature

自然

and developed in the

并在

Mahmood Lab

马哈茂德实验室

, led by Faisal Mahmood, PhD at Mass General Brigham. PathChat integrates advanced generative AI and multimodal analysis which are designed to assist pathologists in diagnosing complex cases with greater accuracy and efficiency. PathChat leverages a unique combination of pathology foundation models, pretrained on extensive histology image and image-text datasets, and a custom trained multimodal large language model (MLLM) to analyze high-resolution pathology images and clinical data..

由马萨诸塞州布莱根将军费萨尔·马哈茂德博士领导。PathChat集成了先进的生成人工智能和多模式分析，旨在帮助病理学家以更高的准确性和效率诊断复杂病例。PathChat利用病理学基础模型的独特组合，对广泛的组织学图像和图像文本数据集进行预训练，并利用定制的多模式大型语言模型（MLLM）来分析高分辨率病理学图像和临床数据。。

With this designation, Modella AI will benefit from prioritized FDA review and increased collaboration with the agency, expediting the development and commercialization process for PathChat DX. The designation highlights the FDA’s recognition of the platform’s potential to address critical challenges in pathology, including diagnostic variability and increasing case volumes..

通过这一指定，Modella AI将受益于FDA的优先审查和与该机构的合作，加快PathChat DX的开发和商业化进程。该名称突显了FDA对该平台解决病理学关键挑战的潜力的认可，包括诊断变异性和病例数量的增加。。

“

“

The Breakthrough Device Designation is a testament to the transformative potential of PathChat DX as one of the first generative AI tools specifically trained for human pathology,” said Dr. Jill Stefanelli, CEO of Modella AI. “

Modella AI首席执行官吉尔·斯特凡内利（JillStefanelli）博士说：“突破性的设备设计证明了PathChat DX作为第一个专门为人类病理学培训的生成性人工智能工具之一的变革潜力。”

This milestone brings us closer to our mission of using generative and agentic AI to accelerate diagnostic workflows.”

这一里程碑使我们更接近使用生成和代理人工智能来加速诊断工作流程的使命。”

“

“

PathChat DX represents a transformative step forward for pathologists at every stage of their career. By enhancing diagnostic precision and potentially accelerating the time to diagnosis, it addresses critical needs in patient care, where timely and accurate decisions directly impact treatment outcomes,” said .

PathChat DX代表着病理学家在其职业生涯的每个阶段都向前迈出了变革性的一步。通过提高诊断精度并可能加快诊断时间，它解决了患者护理的关键需求，及时准确的决策直接影响治疗结果，”他说。

Alexander Lazar

亚历山大·拉扎尔

MD, PhD, Professor & Surgical Pathologist at The University of Texas MD Anderson Cancer Center and Scientific Advisor to Modella AI. “

医学博士，德克萨斯大学安德森癌症中心教授兼外科病理学家，Modella AI科学顾问。”

With the rising demands and challenges in pathology, including growing workloads and burnout, tools like PathChat DX offer an opportunity to help pathologists improve both their efficiency and resilience in our complex field.”

随着病理学需求和挑战的不断增加，包括工作量和职业倦怠的增加，PathChat DX等工具提供了一个机会，可以帮助病理学家在我们复杂的领域提高效率和恢复能力。”

About Modella AI

关于Modella AI

Modella AI (

模型AI(

www.modella.ai

www.modella.ai

) is a Boston-based biomedical AI company dedicated to advancing healthcare through the development of cutting-edge generative and agentic AI technologies. By combining expertise in artificial intelligence and pathology, Modella AI aims to deliver innovative solutions that empower clinicians, improve patient outcomes, and transform medical workflows..

)是一家总部位于波士顿的生物医学人工智能公司，致力于通过开发尖端的生成和代理人工智能技术来推进医疗保健。通过结合人工智能和病理学方面的专业知识，Modella AI旨在提供创新解决方案，赋予临床医生权力，改善患者预后，并改变医疗工作流程。。

Disclaimer:

免责声明：

The FDA Breakthrough Device Designation does not imply FDA clearance or approval. PathChat DX is currently undergoing further testing and evaluation to ensure compliance with regulatory standards and clinical safety requirements. This release may contain forward-looking statements based on current assumptions and forecasts made by Modella AI management.

FDA突破性设备名称并不意味着FDA批准或批准。PathChat DX目前正在进行进一步的测试和评估，以确保符合监管标准和临床安全要求。本版本可能包含基于Modella AI管理层当前假设和预测的前瞻性声明。

The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments..

公司不承担更新这些前瞻性声明或使其符合未来事件或发展的任何责任。。