{"entity":{"id":"paige-prostate","kind":"drug","name":"Paige Prostate Detect","aka":[],"tldr":"The first AI for reading biopsy slides authorised by the FDA, which points pathologists to prostate cancer they might otherwise miss.","summary":"Paige Prostate received FDA De Novo authorisation on 21 September 2021 (DEN200080), the first artificial-intelligence software for pathology. In the FDA reader study, pathologists using the software improved cancer detection on prostate biopsy slides, with the agency reporting a 7.3% improvement in detection and a reduction in false negatives. It runs on scanned whole-slide images and highlights areas of concern rather than making the diagnosis. Paige, a Memorial Sloan Kettering spin-out, went on to build the Virchow foundation models with Microsoft, and the software is CE-marked in Europe.","status":"approved","asOf":"2026-09-10","links":[{"label":"FDA De Novo DEN200080","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200080"},{"label":"FDA press release (2021) (archived copy)","url":"https://web.archive.org/web/20250427051345/https://www.fda.gov/news-events/press-announcements/fda-authorizes-software-can-help-identify-prostate-cancer"}],"tags":["test"],"related":[],"cancers":["prostate"],"sections":[],"technologies":["digital-pathology-ai","whole-slide-scanners","pathology-foundation-model"],"targets":[],"drugs":[],"companies":["paige"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["What a result means: nothing changes for the patient directly; the pathologist still makes the diagnosis, with a second pair of algorithmic eyes reducing missed small cancers."],"brand":"Paige Prostate","modality":"AI digital pathology detection software (prostate biopsy)","mechanism":"Deep-learning model trained on tens of thousands of whole-slide images flags biopsy slides and regions suspicious for cancer for pathologist review.","approvals":[{"region":"US","year":2021,"indication":"Aid to pathologists in detecting areas suspicious for cancer on prostate needle biopsy slides (De Novo)"},{"region":"EU","year":2019,"indication":"CE mark"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/paige-prostate/","neighbours":{"cancer":[{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"technology":[{"id":"digital-pathology-ai","kind":"technology","name":"Digital pathology & AI","route":"/technologies/digital-pathology-ai/"},{"id":"pathology-foundation-model","kind":"technology","name":"Pathology & radiology foundation models","route":"/technologies/pathology-foundation-model/"},{"id":"whole-slide-scanners","kind":"technology","name":"Whole-slide scanners and image management","route":"/technologies/whole-slide-scanners/"}],"company":[{"id":"paige","kind":"company","name":"Paige AI","route":"/companies/paige/"}],"roadmap":[{"id":"ai-oncology-roadmap","kind":"roadmap","name":"AI in oncology roadmap: pattern readers → foundation models → agents in the workflow","route":"/roadmaps/ai-oncology-roadmap/"}]}}