Proscia Receives New FDA 510(k) Clearance for Concentriq AP-Dx with Predetermined Change Control Plan
Regulatory milestone advances Proscia’s open approach to digital pathology
PHILADELPHIA, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Proscia® has received a new 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 year1, 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.
“Laboratories choose a digital pathology platform with the expectation that it will 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 that investment, giving customers confidence that Concentriq AP-Dx will continue to be an interoperable foundation as their needs evolve.”
Proscia earned the top score for supporting customers' integration goals in KLAS Research's Digital Pathology 2026 report on the U.S. market, based on customer feedback. The company also received the highest overall performance score.2 Proscia serves diagnostic laboratories that manage 12 million patient cases annually, 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 under IVDR.
To learn more about Proscia’s PCCP, read Ian Cadieux's perspective on what it means for diagnostic laboratories here.
About Proscia
Proscia is the pathology AI company rewiring pathology for precision medicine across drug discovery, development, and diagnosis. Its Concentriq platform brings intelligence to the scientists, pathologists, and laboratory leaders behind the most critical decisions in medicine, helping more breakthroughs reach the patients they were made for. Proscia is trusted by 16 of the top 20 pharmaceutical companies and was named Global 2026 Best in KLAS for Digital Pathology in Europe. Learn more at proscia.com, and follow Proscia on LinkedIn and X.
Contact
Sydney Fenkell
VP, Marketing Communications
sydney@proscia.com
215.816.3436
1 American Cancer Society. Cancer Facts & Figures 2026. Available at: https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/2026-cancer-facts-figures.html.
2 KLAS Research. Digital Pathology 2026: Early Adoption & Technology Performance 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.
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