Katie is responsible for the commercial growth of Indica’s clinical image management platforms and clinical AI. Working closely with clinical laboratories, she applies her experience of the clinical market and pathology workflow optimization to support institutions as they transition away from glass. Katie has held a variety of customer-facing roles over the years, entering the digital pathology industry in 2009.
HALO AP® and HALO AP Dx: Pathologist-Centric Enterprise Digital Pathology Platforms
In collaboration with Pathology News
Date: 10 October 2024
Time: 8:00 – 9:00 PDT | 11:00 – 12:00 EDT | 16:00 – 17:00 BST
Location: Webinar
Available On-Demand
Learn how HALO AP® and HALO AP Dx can be used for comprehensive workflows in primary diagnostics
Summary
Join us for this 1-hour webinar to learn about HALO AP platforms with regulatory clearances supporting diagnostic workflows in the US (FDA cleared HALO AP Dx) and in the EU and UK (CE-IVDR marked HALO AP®).
Katie McKinley, VP of Clinical Applications at Indica Labs, will present an introduction to the HALO AP platforms and will demonstrate how they enable efficient diagnostic workflows. Learn how the HALO AP platforms automatically organize images, metadata, gross details, and patient information into cases, facilitate case prioritization and sign-out, and enable ergonomic image navigation. See common anatomic pathology workflows in action and discover how the HALO AP platforms modernize tumor boards and promote streamlined management of clinical trials.
Finally, Katie will demonstrate how HALO Clinical AI products from Indica Labs are seamlessly integrated into HALO AP® and are advancing prostate cancer diagnostics, enabling standardized scoring of IHC slides for breast and lung cancer, and facilitating slide quality control and tissue macrodissection.
Learning Objectives
- Learn where the HALO AP platforms fit within the current regulatory landscape for digital pathology in the US, Europe, and the UK
- Experience common anatomic pathology workflows including evaluation of H&E and IHC images from sign out to reporting
- Learn how the HALO AP platforms provide tools and workflows for efficient image evaluation, management, and collaboration
- Discover clinical trial management and tumor board functionality of the HALO AP platforms
- Learn how HALO Clinical AI products for the analysis of breast, prostate, and lung serve as decision-support tools in the HALO AP® platform
Regulatory Text
HALO AP Dx (K232833) is FDA-cleared for primary diagnostic use with the Hamamatsu NanoZoomer® S360MD Slide scanner in the USA. In addition, HALO AP Dx provides built-in compliance with FDA 21 CFR Part 11 and HIPAA.
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 USA and is not FDA cleared for clinical diagnostic use. In addition, HALO AP® provides built-in compliance with FDA 21 CFR Part 11, HIPAA, and GDPR.
HALO AI Prostate is CE-marked for in-vitro diagnostic use in Europe, the UK, and Switzerland. HALO AI Prostate is For Research Use Only in the USA and is not FDA cleared for clinical diagnostic use. HALO AI Prostate is accessed via the HALO AP® enterprise digital pathology platform.
SlideQC BF is intended to be used as a quality control tool for whole slide images and is not regulated as a medical device in the EU/UK. SlideQC BF is for Research Use Only in the USA and is not FDA cleared for clinical diagnostic use. SlideQC BF is accessed via the HALO AP® enterprise digital pathology platform.
Lung Macrodissect AI is not a medical device in the EU/UK and is not intended to be used for diagnostic purposes. Lung Macrodissect AI is accessed via the HALO AP® enterprise digital pathology platform. Lung Macrodissect AI is For Research Use Only in the USA and is not FDA cleared for clinical diagnostic use.