AI Tool Identifies Slide Artifacts to Speed Digital Pathology Diagnosis

At the same time, whole-slide images may contain quality defects such as air bubbles, pen marks, missing or clipped tissue, out-of-focus regions, and striping, leading to rescans and rework. A new system now combines FDA-cleared, AI-assisted quality control with expanded clinical scanning options to help laboratories deliver consistent digital images more efficiently.

Leica Biosystems has received multiple U.S. Food and Drug Administration (FDA) 510(k) clearances that expand its connected clinical digital pathology portfolio. The clearances cover Aperio iQC DX software, the Aperio GT 180 DX scanner, and enhanced capabilities for the Aperio GT 450 DX scanner. Together, the additions are designed to give laboratories greater flexibility to scale digital pathology workflows while maintaining speed, image quality, and consistency.

According to Leica Biosystems, Aperio iQC DX is the industry’s first standalone AI-assisted quality control software for clinical digital pathology. The software analyzes whole-slide images while slides remain on the scanner and automatically flags six common artifacts: air bubbles, pen marks, clipped tissue, missing tissue, out-of-focus regions, and image striping. By identifying quality issues earlier in the workflow, the system is intended to reduce rescanning and downstream delays while supporting more consistent and reproducible image review.

The regulatory clearances also introduce the Aperio GT 180 DX scanner for mid-volume laboratories and expand the capabilities of the high-throughput Aperio GT 450 DX scanner for more complex caseloads. The GT 450 DX offers a 450-slide capacity, a high level of automation, and a small footprint, while the latest release adds manual scanning options for complex slides, Digital Imaging and Communications in Medicine (DICOM) capabilities, and clinical z-stacking. The GT 180 DX provides a 180-slide capacity while offering the same scan speed and comprehensive feature set as the GT 450 DX, supporting connected workflows and timely case review.

In a real‑world data study with the Institute of Pathology, Heidelberg University, the AI models in Aperio iQC DX detected up to 24% more artifacts missed by histotechnicians and reduced hands‑on review time by 69%. All images must be reviewed by the user. The portfolio is designated for in vitro diagnostic use.

“Every improvement in the pathology workflow matters because patients and clinicians are waiting for answers that guide care. These FDA 510(k) clearances demonstrate Leica Biosystems' leadership in advancing digital pathology beyond individual products toward connected, standardized workflows that help laboratories operate with greater confidence and consistency. By embedding AI-assisted quality control directly into the scanning workflow and expanding clinical scanning options, we are enabling laboratories to scale digital pathology in ways that support timely diagnosis, pathologist efficiency and better care for patients,” said Naveen Chandra, Vice President and General Manager of Digital Pathology at Leica Biosystems.

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