The U.S. Food and Drug Administration (FDA) has granted multiple 510(k) clearances to Leica Biosystems for digital pathology technology, designed to assist pathology laboratories in delivering high-quality digital images with greater consistency and efficiency.

The cleared innovations include an AI-assisted quality control software, the Aperio iQC DX, as well as the new Aperio GT 180 DX scanner, and the enhanced Aperio GT 450 DX scanner.

Leica Biosystems stated that the Aperio iQC DX is the industry’s first FDA-cleared software product for digital pathology quality control in a clinical setting. The software automatically detects common artifacts and issues, such as air bubbles and image striping, during the scanning process. Then these issues can be resolved earlier in the digital pathology workflow, limiting rescanning needs and downstream delays.

The company noted that the AI models detected up 24% more artifacts than histotechnicians in a real-world data study conducted with the Institute of Pathology, Heidelberg University, and reduced hands-on review time by 69%.

“Every improvement in the pathology workflow matters because patients and clinicians are waiting for answers that guide care,” stated Naveen Chandra, Vice President and General Manager of Digital Pathology at Leica Biosystems. “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.”

The new and enhanced scanners also build upon the company’s clinical scanning portfolio to meet the wide-ranging needs of various sized laboratories. The Aperio GT 180 DX scanner is meant for mid-volume laboratories trying to scale their digital pathology and develop connected workflows, with a capacity of 180 slides.

New manual scan capabilities were added to the Aperio GT 450 DX scanner to allow for the scanning of more complex slides, as well as advanced DICOM and z-stacking capabilities. The high-throughput scanner has a capacity of 450 slides for rapid conversion into digital images. All scanners are intended for in vitro diagnostic use to move toward diagnosis more rapidly.

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