Indica Labs’ HALO AP Dx digital pathology platform for primary diagnostics has received FDA 510(k) clearance with Leica Biosystems’ Aperio GT 450 DX Scanner and is cleared for use with both SVS and DICOM file formats.

ALBUQUERQUE, NM, and VISTA, CA, December 3, 2025 – Indica Labs, the global leader of AI-powered digital pathology, and Leica Biosystems, a global leader in anatomic and digital pathology solutions, announced today that the Food and Drug Administration (FDA) has issued a 510(k) clearance for the enterprise digital pathology platform HALO AP Dx in conjunction with Leica Biosystems Aperio GT 450 DX Scanner for in-vitro diagnostic use. This impressive combination of FDA-cleared digital pathology solutions provides pathologists with high-performing scanners that support both SVS and DICOM image files with a comprehensive platform for diagnostic workflows in digital pathology.

This latest 510(k) clearance for the HALO AP Dx platform is a major step forward in terms of interoperability and improved functionality. The clearance further validates HALO AP Dx with Leica Biosystems’ Aperio GT 450 DX Scanner as safe and effective for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue by meeting the standards of the FDA and will lay the foundation for medical institutions to confidently adopt and implement digital pathology in clinical workflows.

The unification of these powerful digital pathology solutions addresses current and future needs across the field. The SVS file format provides users with continued use of existing slide archives and scanners, while the DICOM file format ensures seamless integration with existing hospital infrastructure such as PACS, VNAs, and EMRs. This architecture future proofs digital pathology adoption and lays a foundation for multidisciplinary collaboration in a shared digital environment as DICOM file formats are already the standard medical image format used in radiology, cardiology, oncology, surgery, dermatology, and obstetrics and gynecology. This FDA clearance represents a major advancement toward accessible, remote, and digitally driven diagnostics that support comprehensive patient care without logistical barriers.

“This 510(k) clearance combining the Aperio GT 450 DX Scanner with HALO AP Dx marks another significant milestone in providing best in class, integrated solutions for on-screen clinical diagnostics,” said Naveen Chandra, Vice President and General Manager of Digital Pathology at Leica Biosystems. “Since announcing the strategic agreement between Leica Biosystems and Indica Labs earlier this year we have delivered new cutting-edge solutions, such as Aperio HALO AP and the Aperio AI store. This latest FDA clearance is testament to our shared rapid pace of innovation which will continue in 2026 and beyond.”

The Aperio GT 450 DX is an automated, high-capacity scanner that delivers exceptional image quality, and HALO AP Dx is an enterprise digital pathology platform and image management system. Together, they unite high-quality whole slide images with a digital pathology platform equipped with robust pathology-centric tools for efficient and accurate diagnostics. HALO AP Dx supports remote collaboration through secure URL sharing, external consultations, and case conferencing, while enhancing clinical trial management, blind scoring, and meticulous case organization for multidisciplinary team meetings. Additionally, HALO AP Dx can be deployed in either a cloud-based or on-premises environment, for flexible deployment and data management.  

“Uniting Leica Biosystems’ industry-leading scanner and Indica Labs’ enterprise digital pathology platform, we have set a new diagnostic standard, ensuring that past, present, and future whole slide image data can be used to advance medical diagnostics and drug discovery,” said Steven Hashagen, CEO at Indica Labs. “This is just the beginning of what our partnership can do for advancing the field of medicine.”

The clearance comes at a vital time, as pathology faces growing volumes and complexity in addition to clinical workforce shortages. Digital pathology platforms like HALO AP Dx help laboratories address these challenges by streamlining diagnostic workflows and creating new opportunities for remote collaboration, innovation, and scale.

HALO AP Dx (K252762) is FDA-cleared for primary diagnostic use with the Leica Biosystems’ Aperio GT 450 DX Scanner and 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. PRR-MAR-000003v1

Aperio HALO AP is CE marked under IVDR for in-vitro diagnostic use. Algorithms available from the Aperio AI Store, exclusive to Aperio HALO AP, may have different regulatory classifications. Not all products are available in all regions.

About 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. 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.   

About Leica Biosystems:

Leica Biosystems is a cancer diagnostics company and a global leader in anatomic and digital pathology solutions. 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. The company’s mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of its corporate culture. Leica Biosystems is proud to be a Danaher Corporation subsidiary.

Aperio is a registered trademark of Leica Biosystems Imaging, Inc. in the USA and optionally in other countries. GT and GT 450 are trademarks of Leica Biosystems Imaging, Inc. in the USA and optionally in other countries.

Indica Labs Media Contact:

Kim Collins

kcollins@indicalab.com

Leica Biosystems Media Contact:

Matthew McCutcheon

matthew.mccutcheon@leicabiosystems.com