Vista, California, August,11, 2026
Leica Biosystems, a Danaher company and global provider of anatomic and digital pathology solutions, has announced multiple U.S. Food and Drug Administration (FDA) 510(k) clearances expanding its connected clinical digital pathology portfolio. The regulatory milestones include Aperio iQC DX software, described by the company as the industry’s first standalone AI-assisted quality-control software cleared for clinical digital pathology, as well as the Aperio GT 180 DX clinical scanner and enhanced capabilities for the Aperio GT 450 DX scanner. The technologies are designed to help pathology laboratories improve workflow efficiency, image quality and consistency while supporting faster and more confident cancer diagnoses.
FDA Clearances Advance AI-Assisted Pathology Quality Control
The newly cleared Aperio iQC DX software introduces AI-assisted quality control earlier in the digital pathology workflow. Whole-slide images can contain artifacts caused by tissue preparation, staining, coverslipping or scanning, including air bubbles, pen marks, clipped tissue, missing tissue, out-of-focus regions and image striping. According to Leica Biosystems, the software can automatically detect these six common image-quality issues while slides remain on the scanner, allowing laboratories to identify and address potential problems before images move further downstream.
By identifying quality concerns earlier, Aperio iQC DX is designed to help laboratories reduce rescanning and rework, minimize workflow delays and support more consistent image review. Leica Biosystems said real-world data from the Institute of Pathology at Heidelberg University showed that the AI models detected up to 24% more artifacts than histotechnicians and reduced hands-on review time by 69%. These findings support the potential of automated quality control to reduce repetitive manual tasks and allow skilled laboratory professionals to focus on higher-value activities within the diagnostic workflow.
Aperio Scanners Expand Digital Pathology Capacity
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Leica Biosystems is also expanding its clinical scanning capabilities through the Aperio GT 180 DX and enhancements to the Aperio GT 450 DX. The high-throughput GT 450 DX is designed for laboratories managing complex and high-volume caseloads, with a 450-slide capacity and automated scanning capabilities intended to accelerate conversion of glass slides into digital images for clinical review. The latest enhancements include manual scanning capabilities for complex slides, advanced DICOM capabilities and z-stacking for clinical applications. The newly introduced Aperio GT 180 DX extends Leica Biosystems’ clinical scanning portfolio to mid-volume laboratories. With a capacity of 180 slides, the scanner is designed to provide laboratories with a more scalable option based on their case volumes, staffing models and workflow requirements.
Leica Biosystems said the system maintains the same scan speed and comprehensive feature set as the GT 450 DX, helping laboratories establish connected digital pathology workflows while accommodating different operational needs. Together, the new scanning technologies and AI-assisted quality-control software are intended to connect multiple stages of the pathology process, from slide preparation and scanning through digital review and diagnosis. This approach reflects the company’s focus on moving laboratories beyond basic digitization toward standardized, connected and scalable clinical workflows.
Digital Pathology Supports Faster Cancer Diagnosis
The expanded portfolio comes as pathology laboratories face increasing case volumes, staffing pressures and diagnostic complexity. By combining automated quality control with expanded scanning capacity, Leica Biosystems aims to help laboratories improve consistency and reduce workflow variability while supporting pathologists with high-quality digital images. Naveen Chandra, Vice President and General Manager of Digital Pathology at Leica Biosystems, said the FDA clearances demonstrate the company’s focus on advancing digital pathology toward connected workflows that can support timely diagnosis, pathologist efficiency and patient care. Leica Biosystems reported that its solutions support nearly 2 million cancer tests globally each week, highlighting the scale of its involvement in cancer diagnostics. The FDA clearances represent an important development in clinical digital pathology and AI-assisted diagnostic workflows.
By introducing AI-based quality control directly into the scanning process and offering additional scanning capacity for different laboratory environments, Leica Biosystems is expanding the tools available to pathology laboratories seeking greater efficiency and consistency. The technologies remain intended to support clinical professionals, with the company noting that all images must be reviewed by the user. The developments reinforce the growing role of AI, digital pathology and FDA-cleared medical software in modern cancer diagnostics, while providing laboratories with new technologies designed to help move cases from slide preparation to diagnosis more efficiently.
Source: Leica Biosystems press release
