Digital Pathology: Ops Problem

Digital pathology is moving from pilot projects to lab operations, and KLAS said on February 27 that fewer than 15% of U.S. healthcare organizations have selected a digital pathology vendor. (klasresearch.com) Digital pathology turns glass slides into high-resolution files that pathologists review on screens instead of microscopes. The College of American Pathologists says those images are created by scanning slides into whole-slide images that can be stored, shared, and used for diagnosis. (cap.org) In the United States, adoption has accelerated after new Food and Drug Administration clearances and new billing pathways for slide digitization. KLAS said those two changes helped push the market forward even as the customer base remains small. (klasresearch.com) The reimbursement piece is recent and concrete. The Digital Pathology Association said 13 Category III slide-digitization codes were already in effect in 2023 and 30 more became effective on January 1, 2024. (digitalpathologyassociation.org) The regulatory piece is also still moving. The Food and Drug Administration cleared Roche Digital Pathology Dx with the VENTANA DP 200 scanner on June 14, 2024, cleared Philips IntelliSite Pathology Solution 5.1 on March 6, 2025, and cleared PathAI AISight Dx on June 26, 2025. (accessdata.fda.gov) Those approvals do not make rollout simple inside a lab. KLAS described the U.S. market as “early adoption,” and early adopters are now dealing with scanner capacity, image-management software, storage, validation, and day-to-day workflow design rather than whether digital pathology is real. (klasresearch.com) Cytology makes that harder. A 2023 review in *Cancer Cytopathology* said digital cytology implementation remains difficult in routine practice, and a 2023 five-year institutional report said adoption has lagged because of technical limitations. (sciencedirect.com) (springer.com) One reason is the image itself. Cytology slides can contain scattered cells across multiple focal planes, so labs often need more complex scanning and review than they do for standard tissue sections. (springer.com) Labs that have already gone digital have been writing down the operational rules. A 2023 *Laboratory Investigation* paper said quality management systems are a prerequisite for clinical-grade digital pathology operations, including controls for image quality, workflow reliability, and ongoing monitoring. (laboratoryinvestigation.org) Vendors are now selling directly into those bottlenecks. Vieworks said in March 2026 that its new LH210 scanner handles up to 210 slides per batch, scans a 15 x 15 millimeter area at 40x in 23 seconds per slide, and was designed to reduce file size to ease storage and transfer demands. (clpmag.com) The next test is whether labs can show sustained workflow gains after installation. KLAS’s early-adoption snapshot suggests the sales pitch has shifted from digitizing slides to proving that scanners, files, validation plans, and staff workflows hold up in routine practice. (klasresearch.com)