Aug. 10, 2026—Proscia received a new FDA 510(k) clearance for the Concentriq AP-Dx, a digital pathology platform for primary diagnosis. The clearance includes compatibility with the Leica Aperio GT 450 DX slide scanner, cloud deployment, and a predetermined change control plan. The PCCP enables Proscia to validate and implement support for additional FDA-cleared scanners, image formats, and displays without requiring further 510(k) submissions.
“Laboratories choose a digital pathology platform with the expectation that it will sit at the center of their practice for years to come,” Ian Cadieux, head of quality and regulatory at Proscia, said in a press release. “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.”
Concentriq AP-Dx 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 in vitro diagnostic regulation.