Footnotes

References 

¹Eloy, Catarina et al. “Artificial intelligence-assisted cancer diagnosis improves the efficiency of pathologists in prostatic biopsies.” Virchows Archiv : an international journal of pathology vol. 482,3 (2023): 595-604. doi:10.1007/s00428-023-03518-5

²Perincheri, S., Levi, A.W., Celli, R. et al. “An independent assessment of an artificial intelligence system for prostate cancer detection shows strong diagnostic accuracy.” Mod Pathol 34, 1588–1595 (2021)

³da Silva, Leonard M., et al. “Independent real-world application of a clinical-grade automated prostate cancer detection system.” Journal of Pathology 254.2 (2021): 147-158

⁴Raciti, Patricia., Sue, Jillian., et al. “Clinical Validation of Artificial Intelligence Augmented Pathology Diagnosis Demonstrates Significant Gains in Diagnostic Accuracy in Prostate Cancer Detection.” Archives of Pathology & Laboratory Medicine (2022)

⁵Retamero, Juan Antonio MD, MSc*; Gulturk, Emre MSc*; Bozkurt, Alican MSc*; Liu, Sandy MD†; Gorgan, Maria MD†; Moral, Luis MD†; Horton, Margaret PhD*; Parke, Andrea PhD*; Malfroid, Kasper MSc*; Sue, Jill MS*; Rothrock, Brandon PhD*; Oakley, Gerard MD*; DeMuth, George MS‡; Millar, Ewan BSc, FRCPath*,§; Fuchs, Thomas J. DSc*,∥,; Klimstra, David S. MD*. Artificial Intelligence Helps Pathologists Increase Diagnostic Accuracy and Efficiency in the Detection of Breast Cancer Lymph Node Metastases. The American Journal of Surgical Pathology 48(7):p 846-854, July 2024. | DOI: 10.1097/PAS.0000000000002248 

⁶Flach RN, van Dooijeweert C, Nguyen TQ, Lynch M, Jonges TN, Meijer RP, Suelmann BBM, Willemse PM, Stathonikos N, van Diest PJ. Prospective Clinical Implementation of Paige Prostate Detect Artificial Intelligence Assistance in the Detection of Prostate Cancer in Prostate Biopsies: CONFIDENT P Trial Implementation of Artificial Intelligence Assistance in Prostate Cancer Detection. JCO Clin Cancer Inform. 2025 Mar;9:e2400193. doi: 10.1200/CCI-24-00193. Epub 2025 Mar 4. PMID: 40036728. 

⁷Vorontsov, E., Bozkurt, A., Casson, A. et al. A foundation model for clinical-grade computational pathology and rare cancers detection. Nat Med 30, 2924–2935 (2024). https://doi.org/10.1038/s41591-024-03141-0 

Regulatory 

ⁱRefer to the product-specific labeling for the regulatory status of each AI-assisted diagnostic application. When Research Use Only products are used with IVD products, the integrated workflow will be for Research Use Only (RUO) and cannot be used for diagnostic procedures. 

ⁱⁱCE-IVD marked. In the US, Paige Prostate Detect (DEN200080) is approved to assist pathologist in the detection of foci that are suspicious for cancer as detailed in the intended use.

ⁱⁱⁱCE-IVD marked. For Research Use Only (RUO) in the US. Not for use in diagnostic procedures in the US. 

ⁱᵛCE-IVDR marked. K241273 and K201005.

⁺For Research Use Only (RUO). Not for use in diagnostic procedures.