Paige Prostate for prostate cancer

Regulatory information

Paige Prostate and FullFocus whole slide image Viewer are classified as General in vitro diagnostic devices in the US, UK and EU. Both are currently registered with the USFDA as Class II IVD devices and the Dutch authority as General IVDs (self‑certified). Paige has an active project in place to transition to IVDR (2017/746), where both FullFocus and Paige Prostate will be classified as Class C devices. Paige Prostate has recently been granted market authorisation from the USFDA (September 2021).