Original from: Proscia
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 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.
“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. 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.
Source: Proscia Receives New FDA 510(k) Clearance for Concentriq AP-Dx with Predetermined Change Control Plan
