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The first AI for reading biopsy slides authorised by the FDA, which points pathologists to prostate cancer they might otherwise miss.
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.
Deep-learning model trained on tens of thousands of whole-slide images flags biopsy slides and regions suspicious for cancer for pathologist review.
1.Paige Prostate Detect slips into a pocket on its target.
| Region | Year | Indication |
|---|---|---|
| US | 2021 | Aid to pathologists in detecting areas suspicious for cancer on prostate needle biopsy slides (De Novo) |
| EU | 2019 | CE mark |
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Query for this drug: (TITLE:"Paige Prostate Detect" OR ABSTRACT:"Paige Prostate Detect" OR TITLE:"Paige Prostate" OR ABSTRACT:"Paige Prostate") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Paige Prostate Detect, not a curated reading list.
Shares Prostate cancer and the tag test.
Shares Prostate cancer and the tag test.
Shares Prostate cancer and the tag test.
Shares Prostate cancer and the tag test.
Shares Prostate cancer and the tag test.
Shares Whole-slide scanners and image management, Digital pathology & AI.
Shares Pathology & radiology foundation models, Digital pathology & AI, Prostate cancer.
Shares Whole-slide scanners and image management, Digital pathology & AI.