Leica Biosystems Enables Faster Cancer Diagnoses Through Multiple Digital Pathology FDA Clearances, Including Industry-First AI-Assisted Quality Control Software

Portfolio expansion marks new era for diagnosis delivery, translating digital pathology innovation to clinical impact by accelerating workflows and patient care

VISTA, Calif., Aug. 11, 2026 /PRNewswire/ -- Leica Biosystems, a Danaher company and a global leader in end-to-end anatomic and digital pathology solutions, today announced multiple U.S. Food and Drug Administration (FDA) 510(k) clearances that strengthen its connected clinical digital pathology portfolio, including the industry's first standalone, AI-assisted quality control software. These advancements are designed to help pathology laboratories deliver high-quality digital images more consistently and efficiently to support timely, confident diagnoses for patients at a critical moment when case volumes, staffing pressures, and diagnostic complexity continue to increase.

These FDA 510(k)-cleared innovations reinforce Leica Biosystems' commitment to enabling better care for patients by helping laboratories move beyond digitization toward more connected, standardized, and scalable clinical workflows. The expanded U.S. clinical portfolio introduces Aperio iQC DX software, adds the Aperio GT 180 DX scanner, and enhances capabilities for the Aperio GT 450 DX scanner—providing laboratories with greater flexibility to scale digital pathology while maintaining speed and quality.

Introducing AI-Assisted Quality Control Earlier in the Workflow
As the industry's first FDA 510(k)-cleared software product for AI-assisted digital pathology quality control in a clinical setting, Aperio iQC DX software represents a significant step forward in accelerating time to diagnosis. Whole slide images can be affected by artifacts introduced during tissue preparation, staining, coverslipping or scanning—such as air bubbles, pen marks, clipped tissue, missing tissue, out-of-focus regions and image striping.

By detecting these six common issues automatically while slides remain on the scanner, Aperio iQC DX software enables laboratories to identify and resolve potential quality concerns earlier in the workflow. This helps reduce the need for rescanning or rework, minimize downstream delays, and support more consistent, reproducible image review to help pathologists deliver answers with greater speed and certainty when every moment matters.

In a real-world data study, the AI models detected up to 24%* more artifacts missed by histotechnicians and reduced hands-on review time by 69%*, helping laboratories reallocate skilled staff to higher-value tasks and keep cases moving efficiently through the diagnostic process.

Cutting-Edge Scanning Solutions for Routine Diagnostics
Leica Biosystems continues to expand its clinical scanning portfolio to meet the needs of laboratories across a range of volumes and workflow requirements. With broad global adoption, the high-throughput Aperio GT 450 DX clinical scanner is proven to deliver the speed, quality, and capacity needed to manage complex caseloads. The 450-slide capacity, industry-leading automation, and small footprint enables rapid conversion of glass slides into digital images for clinical review and confidence in results, supporting the faster movement of cases through the diagnostic pathway. This latest release includes new manual scan capabilities for more complex slides, advanced DICOM capabilities, and z-stacking for the clinical environment.

The Aperio GT 180 DX clinical scanner extends Leica Biosystems' clinical scanning portfolio to mid-volume laboratories seeking to scale digital pathology in a way that fits their case mix, staffing model, and operational needs. With a smaller 180-slide capacity and the same scan speed and comprehensive feature set as the Aperio GT 450 DX scanner, the Aperio GT 180 DX scanner helps laboratories build connected digital pathology workflows that can support timely review, diagnostic confidence, and better care delivery.

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

This expanded portfolio helps laboratories move from slide preparation to diagnosis with greater speed, consistency and less variability, underscoring Leica Biosystems' differentiated ability to support digital transformation across the full clinical pathology workflow. As part of Danaher's connected ecosystem of life sciences and diagnostics companies, Leica Biosystems supports nearly 2 million cancer tests globally each week. By connecting solutions from biopsy to diagnosis, Leica Biosystems helps laboratories turn complexity into clarity—enabling more reliable decisions and better outcomes for patients worldwide.

For more information on clinical digital pathology solutions from Leica Biosystems, click here.

For In Vitro Diagnostic Use.

* Based on a Real-World Data Study with Institute of Pathology, Heidelberg University. All images must be reviewed by the user.

About Leica Biosystems
Leica Biosystems is a cancer diagnostics company and a global leader in end-to-end anatomic and digital pathology solutions. The company offers a comprehensive product range for each step in the pathology process, from sample preparation and staining to imaging and reporting. As the only company to own the full workflow from biopsy to diagnosis, Leica Biosystems is uniquely positioned to break down the barriers between each step. The company's mission of 'Advancing Cancer Diagnostics, Improving Lives' is at the heart of its corporate culture. Leica Biosystems is proud to be a Danaher Corporation subsidiary. Learn more at www.leicabiosystems.com.

About Danaher
Danaher is a leading global life sciences and diagnostics innovator, committed to accelerating the power of science and technology to improve human health. Through our connected ecosystem of industry-leading businesses, we work side by side with customers to solve their most complex scientific and clinical challenges—helping move innovations from discovery to delivery faster for patients who depend on them. Powered by the Danaher Business System, our advanced science and technology and proven ability to innovate help enable faster, more accurate diagnoses and reduce the time, cost, and risk required to discover, develop, and deliver life-changing therapies. Through continuous improvement and operational excellence, our approximately 60,000 associates worldwide are focused on delivering lasting impact and improving quality of life around the world, while building a healthier, more sustainable tomorrow. Explore more at www.danaher.com.

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SOURCE Leica Biosystems