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Proscia Nabs US FDA 510(k) Clearance for Digital Pathology Software

NEW YORK – Proscia on Monday said it has secured US Food and Drug Administration 510(k) clearance for its digital pathology software that is used to aid the analysis of whole-slide images.

The Philadelphia-based firm said its Concentriq AP-Dx is used to aid the viewing, interpretation, and management of digital slide images that are used for the primary diagnosis of cancer. The software is cleared for use with the Hamamatsu NanoZoomer S360MD Slide scanner, and it is designed for use in clinical settings ranging from reference laboratories to large hospital systems.

A Proscia spokesperson said Concentriq AP-Dx is the same as the company's Concentriq Dx software that is CE-IVDR certified for use in the EU, cleared for marketing in the United Kingdom, and licensed by Health Canada. The firm said that more than 10,000 pathologists and scientists use its software.

In March 2023, Proscia inked a multiyear distribution agreement with Agilent Technologies for its Concentriq Dx platform. Agilent noted at the time that Proscia had developed an open platform that could be integrated with other hardware and software solutions.

Proscia said it supported its 510(k) submission with the results of a multisite clinical study, which compared the results of analysis conducted using the firm's software against analysis performed with traditional glass-slide microscopy and found the methods had a major discordance rate of -0.1 percent.