Pathology
Paige Prostate Detect
Paige.AI
FDACE
FDA-cleared AI medical device
First FDA-authorized AI for pathology — identifies regions of interest suspicious for prostate cancer on digitized H&E whole-slide images of core-needle biopsies.
FDA Submission Metadata
- Submission number
- DEN200080
- Decision date
- September 2021
- FDA panel
- Pathology
- Product code
- QPN
- Clinical task (npj)
- detection/diagnosis
- Data modality (npj)
- Images
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals
FDA
US FDA De Novo
DEN200080
CE
EU CE IVDR