Proscia announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its artificial intelligence (AI)-based digital pathology software, Concentriq AP-Dx. This software is designed to assist in the analysis of whole-slide images, particularly for the primary diagnosis of cancer. It facilitates the viewing, interpretation, and management of digital slide images and is compatible with the Hamamatsu NanoZoomer S360MD Slide scanner. The clearance allows its use in various clinical settings, from reference laboratories to large hospital systems.
Concentriq AP-Dx is essentially the same as Proscia’s Concentriq Dx software, which is already certified for use in the European Union (CE-IVDR certified), approved for marketing in the United Kingdom, and licensed by Health Canada. Over 10,000 pathologists and scientists currently utilize Proscia’s software.
Proscia supported its 510(k) submission with the findings of a multi-site clinical study. The results compared the analysis performed using Proscia’s software with traditional glass-slide microscopy, revealing a major discordance rate of -.1 percent. In March 2023, Proscia entered a multiyear distribution agreement with Agilent Technologies, emphasizing the open platform nature of Concentriq Dx that allows integration with various hardware and software solutions.