The first AI-based pathology product to receive FDA marketing authorization and CE approval for in-vitro diagnostic (IVD) use in the detection of prostate cancer on digitized needle biopsy slides. This powerful AI assists pathologists in the detection of suspicious foci, grading and quantification of tissue, and indication of perineural invasion (PNI) in needle core biopsy samples of the prostate. Tested and validated on thousands of biopsies and slides from over 200 institutions, it works on a wide range of data and spans numerous pre-analytical variations, staining techniques, and scanning artifacts without the need for tuning or recalibration. In clinical practice, it can assist in efficiencies of reads and reduce diagnostic errors by precisely identifying cancerous regions of interest, no matter how small. Proven to improve both sensitivity and specificity, Paige Prostate can help pathologists across varying levels of specialization boost diagnostic confidence and workflow efficiencies and deliver accurate results to patients in record time.