Keeping Digital Pathology Open: The Regulatory Framework Behind Concentriq AP-Dx

Interoperability in digital pathology is about more than the ability to open an image file. It means giving pathologists a consistent, trusted experience as laboratories add scanners, displays, and connected systems. Selecting a digital pathology platform for primary diagnosis is a long-term, important decision impacting lab operations and the patients who depend on the results.

Pathologists develop years of familiarity with the software they use to review cases. The laboratory’s LIS, image archive, integrations, and future technology purchases form a technology ecosystem around the software. The digital pathology platform, therefore, has to meet a high bar when it is first deployed and continue meeting that bar as the laboratory’s equipment and workflows evolve.

Our new FDA 510(k) clearance for Concentriq AP-Dx responds to that reality. The clearance adds support for the Leica Aperio GT 450 DX slide scanner and, more importantly, authorizes a Predetermined Change Control Plan, or PCCP, for adding additional FDA-cleared whole slide scanners and their associated image formats, as well as FDA-cleared pathology displays. It turns openness from an architectural principle into a repeatable, regulated process.

The regulatory framework behind it

Historically, adding a new scanner or diagnostic display to a cleared digital pathology platform has typically required a new 510(k) and an associated FDA review cycle before the new configuration could be offered for primary diagnosis. At the end of 2022, Section 515C was added to the Federal Food, Drug, and Cosmetic Act, establishing the legal foundation for FDA to authorize plans for certain future device modifications. A PCCP describes the planned modifications to a device and how those modifications will be developed, validated, implemented, and assessed for their impact on safety and effectiveness. A change that would otherwise require a new 510(k) may then be implemented without a separate marketing submission when it is consistent with the FDA-authorized PCCP, resulting in a more efficient path to market.

A PCCP is not a blank check. It establishes defined boundaries: which types of changes are eligible, what evidence must be generated, what acceptance criteria must be met, how risks will be controlled, and how labeling will be updated. Every future component must still pass the applicable validation protocol before it can be added to the cleared system.

FDA has also invested in regulatory science tools that make this type of evidence generation more standardized and predictable. One such tool, the Image Viewer Integrity Evaluation System (IVIES), provides a common, quantitative method for comparing how two whole slide imaging applications render the same image files at the pixel level. During the review of Concentriq AP-Dx, we confirmed our pixel-wise comparison results by also using the IVIES tool and incorporated the tool into our PCCP. It was a practical demonstration of how collaboration between regulators and manufacturers can make device review more repeatable and efficient.

Together, the PCCP framework and tools such as IVIES represent a thoughtful approach to technological change. As new FDA-cleared scanners and pathology displays enter the market, this framework gives us a defined way to evaluate them against predetermined requirements and, when those requirements are met, support them more efficiently for laboratories.

Looking ahead

The significance of this clearance extends beyond the next scanner or display we add. The evolution in regulatory science is increasingly important as pathology becomes more software-driven. Laboratories are adopting new capabilities, including new scanners, automation, AI-enabled devices, and other computational tools. We also expect computational biomarkers and companion diagnostics to play a growing role in matching patients with appropriate therapies.

Those advances cannot reach their full potential if every new tool requires a laboratory to replace or reconstruct the platform surrounding them because the manufacturer restricted the use to a closed system of specific components. Labs need open platforms that can connect images, clinical context, laboratory systems, and validated applications while continuing to satisfy the requirements of diagnostic use. That is the future we are working toward at Proscia, alongside laboratories, technology partners, industry colleagues, and regulators.

Our new clearance is a significant milestone in that commitment, but not the end. Standardized evaluation tools and PCCPs provide a framework to maintain interoperability in our rapidly advancing field. As pathology adds more AI-enabled devices and computational diagnostics in the years ahead, Proscia intends to keep applying that same framework, so labs can put each new advancement to work on the platform they already have, wherever authorization allows, so that it can benefit patients sooner.