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…