Aiforia vs Tempus Digital Pathology

Prostate biopsy is where these two overlap, and the regulatory gap there is wide. Paige Prostate Detect, now sold by Tempus, holds FDA De Novo DEN200080 from September 2021 and a CE-IVDR mark. Aiforia's Prostate Cancer Biopsy AI is CE-IVD marked with no FDA clearance, and the suite is research use only outside the EU and EEA. On a US reference lab's prostate shortlist, Aiforia drops off. A US cancer center reading prostate cores starts with Tempus, and the scanners and viewers Paige authorizes decide whether it fits the lab. A European academic lab that wants to train its own models, or run suites for breast, lung, colon and gastric slides, gets more from Aiforia. Tempus's other suites are research use only. Tempus bought Paige in August 2025 for $81.25M, mostly in stock, while PitchBook puts Aiforia's 2025 revenue near USD 4.0M after repeated equity raises.