Regulatory milestone advances Proscia’s open approach to digital pathology
PHILADELPHIA — August 6, 2026 — Proscia®has received a new 510(k) clearance from the U.S. Food and Drug Administration(FDA) for Concentriq® AP-Dx. The clearance includes compatibilitywith the Leica Aperio® GT 450 DX slide scanner, cloud deployment,and a Predetermined Change Control Plan (PCCP). Concentriq AP-Dx is a digitalpathology platform for primary diagnosis used by laboratories of all sizes.
Through the PCCP, Proscia gains a moreefficient pathway to expand Concentriq AP-Dx’s interoperability whilemaintaining regulatory oversight. The PCCP enables Proscia to validate andimplement support for additional FDA-cleared scanners, image formats, anddisplays without requiring further 510(k) submissions.
More than 2.1 million Americans are projectedto be diagnosed with cancer this year[1],intensifying the strain on an already declining pathologist workforce.Laboratories are increasingly turning to digital pathology to keep pace withdiagnostic demand and unlock new sources of value. To scale, they must haveflexibility to adopt additional technologies unconstrained by the limits ofproprietary ecosystems.
“Laboratories choose a digital pathology platform with the expectation that itwill sit at the center of their practice for years to come,” said Ian Cadieux,Head of Quality and Regulatory at Proscia. “The PCCP helps us to protect thatinvestment, giving customers confidence that Concentriq AP-Dx will continue tobe an interoperable foundation as their needs evolve.”
Proscia earned the top score for supporting customers' integration goalsin KLAS Research's Digital Pathology 2026 report on the U.S. market,based on customer feedback. The company also received the highest overallperformance score.[2]Proscia serves diagnostic laboratories that manage 12 million patient casesannually, as well as 16 of the top 20 pharmaceutical companies.
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 underIVDR.
To learn more about Proscia’s PCCP, read IanCadieux's perspective on what it means for diagnostic laboratories here.
About Proscia
Proscia is the pathology AI company rewiring pathologyfor precision medicine across drug discovery, development, and diagnosis. ItsConcentriq platform brings intelligence to the scientists, pathologists, andlaboratory leaders behind the most critical decisions in medicine, helping morebreakthroughs reach the patients they were made for. Proscia is trusted by 16of the top 20 pharmaceutical companies and was named Global 2026 Best in KLASfor Digital Pathology in Europe. Learn more at proscia.com, and follow Proscia on LinkedInand X.
[1] American Cancer Society. Cancer Facts &Figures 2026. Available at:
[2] KLASResearch. Digital Pathology 2026: Early Adoption & TechnologyPerformance in an Emerging US Market. Available at:https://klasresearch.com/report/digital-pathology-2026-early-adoption-and-technology-performance-in-an-emerging-us-market/3711.