Device Tracker
FDA-Cleared AI Devices in Pathology
Whole slide image analysis. Authorizations here are rare compared with radiology.
| Device | Manufacturer | Route | Year | Modality | Function |
|---|---|---|---|---|---|
| Paige Prostate | Paige.AI | De Novo | 2021 | Digital pathology | Flags areas suspicious for prostate cancer on digitized slides |