FDA Clears Leica Biosystems AI Software That Flags Flaws in Digital Pathology Slides

The U.S. Food and Drug Administration has cleared Leica Biosystems' Aperio iQC DX, artificial intelligence software that checks digitized pathology slides for quality problems before a pathologist reviews them. The FDA's 510(k) database lists the device under number K253561 with a decision date of August 7, 2026, and classifies it as digital pathology image artifact detection software.

Leica, a Danaher company based in Vista, Calif., announced the clearance on August 11 together with a second clearance for its whole slide imaging scanners, according to the company's release as published on News-Medical.

What the software checks

Whole slide images, the high-resolution scans that let pathologists read tissue on a screen instead of under a microscope, can be spoiled by problems introduced while tissue is prepared, stained, coverslipped or scanned. Leica said Aperio iQC DX detects six common artifacts automatically: air bubbles, pen marks, clipped tissue, missing tissue, out-of-focus regions and image striping. Because the check runs while slides are still on the scanner, labs can catch problems earlier and avoid rescans and delays further down the workflow, the company said.

Leica cited a real-world data study with the Institute of Pathology at Heidelberg University in which, it said, the AI models detected up to 24% more artifacts missed by histotechnicians and cut hands-on review time by 69%. Those figures come from the company's announcement; the FDA database entry does not report performance results. The release adds that all images must be reviewed by the user.

Leica described Aperio iQC DX as the industry's first FDA 510(k)-cleared software product for AI-assisted digital pathology quality control in a clinical setting. The FDA record shows the 510(k) was received on November 17, 2025, and was found substantially equivalent to a device already on the market, the standard for a 510(k) clearance.

A second scanner for smaller labs

The second clearance, 510(k) K253554, covers the Aperio GT 450 DX and Aperio GT 180 DX whole slide imaging systems and carries the same August 7 decision date, according to the FDA database.

Leica said the GT 180 DX is aimed at mid-volume laboratories. It holds 180 slides, compared with 450 for the GT 450 DX, and has the same scan speed and feature set, the company said. The update to the GT 450 DX adds manual scanning for more complex slides, advanced DICOM imaging-standard capabilities and z-stacking for clinical use, according to the release.

"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," said Naveen Chandra, vice president and general manager of digital pathology at Leica Biosystems.

Leica did not disclose pricing or a U.S. launch date for the new software or scanner in the announcement.