Artera vs Tempus Digital Pathology

Paige Prostate Detect, now in the Tempus line, flags possible cancer on prostate biopsy slides. FDA authorized it by De Novo (DEN200080) in September 2021, the vendor claims 20% shorter reading time, and it has to be used with specific scanners and viewers. A pathology lab with prostate biopsy volume is the customer.

ArteraAI Prostate starts after the diagnosis. Its De Novo (DEN240068, July 2025) covers a 10-year risk of distant metastasis and prostate cancer-specific mortality in males 55 or older, from slides scanned on an FDA-cleared interoperable scanner, and a predetermined change control plan was authorized with it. Artera runs the commercial test in its own CLIA lab, so the person choosing it is a urologist deciding on a man's treatment after a biopsy has shown cancer. The lab software and the lab-run test sit at different points in the same patient's care.