Aug. 6, 2026 — Proscia has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Concentriq AP-Dx. The clearance includes compatibility with the Leica Aperio GT 450 DX slide scanner, cloud deployment, and a Predetermined Change Control Plan (PCCP). Concentriq AP-Dx is a digital pathology platform for primary diagnosis used by laboratories of all sizes.
Through the PCCP, Proscia gains a more efficient pathway to expand Concentriq AP-Dx’s interoperability while maintaining regulatory oversight. The PCCP enables Proscia to validate and implement support for additional FDA-cleared scanners, image formats and displays without requiring further 510(k) submissions.
More than 2.1 million Americans are projected to be diagnosed with cancer this year, intensifying the strain on an already declining pathologist workforce. Laboratories are increasingly turning to digital pathology to keep pace with diagnostic demand and unlock new sources of value. To scale, they must have flexibility to adopt additional technologies unconstrained by the limits of proprietary ecosystems.
Concentriq AP-Dx initially received FDA 510(k) clearance for primary diagnosis with the Hamamatsu NanoZoomer S360MD Slide scanner in February 2024. The platform is also CE-marked under IVDR.
To learn more about Proscia’s PCCP, read Ian Cadieux's perspective on what it means for diagnostic laboratories here.
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American Cancer Society. Cancer Facts & Figures 2026. Available atwww.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/2026-cancer-facts-figures.html
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KLAS Research. Digital Pathology 2026: Early Adoption & Technology Performance in an Emerging US Market. Available at klasresearch.com/report/digital-pathology-2026-early-adoption-and-technology-performance-in-an-emerging-us-market/3711
August 14, 2026 
