New KLAS report finds fewer than 15% of US healthcare organizations have selected digital pathology vendors.
Digital pathology adoption in the United States remains in early stages despite rapid growth, with fewer than 15% of US healthcare organizations having selected a digital pathology vendor, according to a new report from KLAS Research.
The KLAS Digital Pathology 2026 report found that while development and use of digital pathology software is growing rapidly thanks to Food and Drug Administration (FDA) clearance for several new vendors and progress toward digital pathology-specific reimbursement, US adoption still lags behind global counterparts.
“Digital pathology is still an emerging market in the US, with a maturing but limited customer base across all vendors,” the report states. Organizations are evaluating a growing range of digital pathology technologies for the first time, including image management systems (IMS), scanners, and artificial intelligence tools.
Pathology-Specific Vendors Show Higher Satisfaction
The report categorizes vendors into two groups: early entrants that expanded into digital pathology from broader imaging or radiology backgrounds, and newer vendors built specifically for pathology. Early customer feedback shows consistently higher satisfaction with pathology-specific vendors.
Proscia emerged as the most frequently considered IMS vendor with one of the largest validated digital pathology deployments within a single organization. Customers cite the vendor’s collaborative, education-focused approach as a key differentiator, expressing confidence in the platform as a long-term solution.
PathAI received positive feedback centered around customer relationships, with respondents highlighting proactive communication and hands-on involvement in integration efforts. LUMEA customers reported satisfaction driven by responsiveness and ease of use, with the vendor’s strategic engagement helping adapt pathology workflows to customer-specific needs.
Traditional imaging vendors including Sectra, Philips, and Fujifilm demonstrated solid but more variable performance. Sectra continues growing quickly through established health system relationships, while Philips customers value system consistency for daily diagnostic work but report slower development around AI integration, according to the report.
Leica Dominates Scanner Market
Leica Biosystems (Aperio GT 450 DX) stands out as the market leader for scanners, being the most widely adopted scanner vendor for clinical use in the US digital pathology market, according to the report. As one of the first scanners to receive FDA clearance, customers consistently highlight high-quality scans, efficient slide loading, strong throughput, and day-to-day reliability.
Other scanner vendors continue to mature, with Hamamatsu Photonics showing strong early satisfaction among its relatively small US customer base. Customers highlight the scanner’s reliability, ease of use, and throughput, though some want improved image quality.
AI Interest Focuses on Clinical Applications
Early indicators point to strong and growing interest in AI for digital pathology, with respondents primarily evaluating AI for clinical use. Breast and prostate cancer algorithms emerged as the most common focus areas, with breast cancer applications supporting biomarker assessment showing particular interest.
Vendor consideration is concentrated among established AI developers including Ibex, Visiopharm, Paige.ai, and PathAI, the report finds. Respondents consistently emphasize the importance of integration into IMS workflows, expecting AI to function as part of routine clinical operations rather than as separate systems.
Adoption Varies by Organization Size
Most organizations transitioning to digital pathology prioritize histology cases over cytology, according to the report. Smaller, more progressive organizations that have made the transition are most likely to be fully digital, reflecting fewer pathologists to align and less validation work required.
Among organizations with more than 25,000 annual cases that have begun converting to digital, adoption averages below 50%. The largest organizations processing 100,000 or more cases report doing just under 40% of their total cases digitally.
The report notes that digital pathology usage remains primarily for histology, with very limited adoption for cytology. KLAS validated only a small number of organizations scanning cytology slides, and volumes remain small when implemented.
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