HALO AP Dx brings digital primary diagnosis to anatomic pathology labs in the US.

HALO AP Dx为美国解剖病理实验室带来了数字初级诊断。

ALBUQUERQUE, NM / ACCESSWIRE / May 8, 2024 / Indica Labs, the leading provider of digital pathology solutions, announced today that it received FDA clearance for HALO AP Dx, an enterprise digital pathology platform, for primary diagnosis. This 510(k) clearance allows HALO AP Dx to be utilized in conjunction with the Hamamatsu NanoZoomer® S360MD Slide scanner for in-vitro diagnostic use and sets the stage for use with additional FDA-cleared slide scanners in the future..

数字病理学解决方案的领先供应商ALBUQUERQUE，NM/ACCESSWIRE/2024年5月8日/Indica Labs今天宣布，它已获得FDA批准用于企业数字病理学平台HALO AP Dx的初步诊断。这510（k）清除率允许HALO AP Dx与Hamamatsu NanoZoomer®S360MD载玻片扫描仪一起用于体外诊断，并为将来与其他FDA清除的载玻片扫描仪一起使用奠定了基础。。

HALO AP® is an enterprise digital pathology platform that is deployed worldwide and has transformed the way pathologists and researchers analyze, manage, and utilize digital pathology images. To address the complex needs of modern pathology laboratories, Indica Labs created HALO AP® and HALO AP Dx with a comprehensive suite of diagnostic tools and features for efficient and accurate image evaluation, management, and collaboration.

HALO AP®是一个部署在全球的企业数字病理学平台，它改变了病理学家和研究人员分析、管理和利用数字病理学图像的方式。为了满足现代病理学实验室的复杂需求，Indica实验室创建了HALO AP®和HALO AP Dx，并提供了一套全面的诊断工具和功能，以实现高效准确的图像评估、管理和协作。

In the US, Indica Labs will continue to offer HALO AP® for RUO applications and will now offer HALO AP Dx for primary diagnosis..

在美国，Indica实验室将继续为RUO应用提供HALO AP®，现在将为初级诊断提供HALO AP Dx。。

'Our team is thrilled to achieve this FDA clearance for HALO AP Dx,' said Steven Hashagen, founder and CEO of Indica Labs. 'Indica Labs is dedicated to improving patient care by providing an ideal environment for the practice of pathology that supports both current and future technologies, ensuring pathologists have the best tools available at their fingertips and are prepared for whatever the future of digital pathology holds.'.

Indica Labs创始人兼首席执行官史蒂文·哈沙根（StevenHashagen）说，我们的团队很高兴能获得FDA对HALO AP Dx的批准Indica实验室致力于改善患者护理，为支持当前和未来技术的病理学实践提供理想的环境，确保病理学家拥有可用的最佳工具，并为数字病理学的未来做好准备。”。

Owing to the company's commitment to open pathology, the platform is highly interoperable. HALO AP Dx users can adapt the platform to meet their needs and incorporate it into their existing laboratory workflows with ease, creating a custom-built environment for digital pathology and for a variety of pathologic specialties, even those with unique technical requirements.

由于该公司致力于开放病理学，该平台具有高度的互操作性。HALO AP Dx用户可以调整平台以满足他们的需求，并轻松地将其纳入现有的实验室工作流程，为数字病理学和各种病理学专业（即使是具有独特技术要求的专业）创建定制环境。

HALO AP Dx is flexible and can be deployed in either a cloud-based or on-premises environment, granting users freedom of choice as to how their data is stored..

HALO AP Dx非常灵活，可以部署在基于云的环境或内部部署环境中，使用户可以自由选择如何存储数据。。

HALO AP Dx brings digital primary diagnosis to anatomic pathology labs in the US.

HALO AP Dx为美国解剖病理实验室带来了数字初级诊断。

In addition to streamlining the diagnostic process, HALO AP Dx enables both remote work and remote consultations, features that are particularly crucial as case numbers increase amid a worsening pathologist shortage. With slides available for review from any location the moment they are scanned, pathology labs can run an uninterrupted pathology service with round-the-clock, global collaboration without having to ship a single slide..

除了简化诊断过程外，HALO AP Dx还可以进行远程工作和远程咨询，随着病理学家短缺的加剧，病例数量的增加，这些功能尤为重要。由于幻灯片在扫描时可以从任何位置进行查看，病理实验室可以不间断地提供全天候的全球合作病理服务，而无需运送一张幻灯片。。

Hashagen added, 'This 510(k) clearance for HALO AP Dx enables pathologists in the US to deliver timely and accurate diagnoses, expediting the development of treatment plans and ultimately resulting in patients being treated sooner, which enhances patient care. We've already witnessed these improvements to patient care in the UK, where the platform is CE-IVDR marked for in-vitro diagnostic use, and we look forward to similar outcomes here in the US.'.

Hashagen补充道，“HALO AP Dx的510（k）清除率使美国的病理学家能够及时准确地进行诊断，加快治疗计划的制定，最终使患者得到更快的治疗，从而提高了患者的护理水平。我们已经见证了英国患者护理的这些改进，该平台被CE-IVDR标记为体外诊断用途，我们期待着在美国取得类似的结果。”。

HALO AP Dx is a complete platform for pathology and a centralized solution for primary diagnosis, collaboration, tumor boards, and second opinions. Its powerful integration engine brings together diverse software and hardware functionalities. With HALO AP Dx, pathology practices gain not only a robust diagnostic workspace but also a collaborative hub that fosters innovation, adaptability, and future AI readiness.

HALO AP Dx是一个完整的病理学平台，是初级诊断，协作，肿瘤委员会和第二意见的集中解决方案。其强大的集成引擎将多种软件和硬件功能结合在一起。通过HALO AP Dx，病理学实践不仅获得了强大的诊断工作空间，而且还获得了一个促进创新，适应性和未来AI准备的协作中心。

Leading hospitals, CROs, clinical laboratories, government and academic organizations trust HALO AP® to provide the power and usability needed to practice modern pathology..

领先的医院，CRO，临床实验室，政府和学术组织相信HALO AP®能够提供实践现代病理学所需的功能和可用性。。

To learn more about HALO AP Dx and to see a live demo, register for Indica Labs' upcoming webinar. 'Introducing HALO AP Dx: An Enterprise Pathology Platform for Primary Diagnosis' will take place on Thursday, June 13 at 11AM EDT.

要了解更多有关HALO AP Dx的信息并观看现场演示，请注册Indica Labs即将举行的网络研讨会介绍HALO AP Dx:Enterprise Pathology Platform for Primary Diagnosis'将于美国东部夏令时6月13日（星期四）上午11点举行。

HALO AP Dx (K232833) is FDA-cleared for primary diagnostic use with the Hamamatsu NanoZoomer® S360MD Slide scanner in the US. In addition, HALO AP Dx provides built-in compliance and certifications with FDA 21 CFR Part 11, ISO 13485:2016, and HIPAA.

HALO AP Dx（K232833）已获得FDA批准，可在美国使用Hamamatsu NanoZoomer®S360MD幻灯片扫描仪进行主要诊断。此外，HALO AP Dx还提供了FDA 21 CFR第11部分，ISO 13485:2016和HIPAA的内置合规性和认证。

HALO AP® is CE-IVDR marked for in-vitro diagnostic use in Europe, the UK, and Switzerland. HALO AP® is For Research Use Only in the US and is not FDA cleared for clinical diagnostic use. In addition, HALO AP® provides built-in compliance and certifications with FDA 21 CFR Part 11, ISO 13485:2016, HIPAA, and GDPR..

HALO AP®是CE-IVDR，用于欧洲、英国和瑞士的体外诊断。HALO AP®仅在美国用于研究，未经FDA批准用于临床诊断。此外，HALO AP®提供了FDA 21 CFR Part 11、ISO 13485:2016、HIPAA和GDPR的内置合规性和认证。。

About Indica Labs

关于Indica Labs

Indica Labs is the global leader in AI-powered digital pathology software and services. Our flagship HALO® and HALO AI platform revolutionizes quantitative evaluation of whole slide images. HALO Link provides collaborative image management while HALO AP® and HALO AP Dx deliver enterprise digital pathology for primary diagnosis with regulatory clearances in multiple markets.

Indica实验室是人工智能驱动的数字病理软件和服务的全球领导者。我们的旗舰HALO®和HALO AI平台彻底改变了整个幻灯片图像的定量评估。HALO Link提供协作图像管理，而HALO AP®和HALO AP Dx在多个市场提供企业数字病理学初步诊断和监管许可。

Through a commitment to open pathology, performance, scalability, and ease-of-use, we help pharma companies, diagnostic labs, hospitals, research organizations, and Indica's own Cloud and Pharma Services make discoveries and diagnoses that transform patient care and scientific discovery..

通过致力于开放病理学、性能、可扩展性和易用性，我们帮助制药公司、诊断实验室、医院、研究组织以及Indica自己的云和制药服务进行发现和诊断，从而改变患者护理和科学发现。。

Indica Labs Media Contact:

Indica Labs媒体联系人：

Eric Runde

Eric Round

erunde@indicalab.com

erunde@indicalab.com

SOURCE: Indica Labs

资料来源：印度实验室

View the original press release on accesswire.com

在accesswire.com上查看原始新闻稿