Paige Prostate
Paige.AI
The first FDA-authorized AI application in digital pathology. Analyzes digitized prostate biopsy slides and identifies regions with the highest likelihood of harboring cancer for pathologist review.
At A Glance
- Manufacturer
- Paige.AI
- Medical specialty
- Pathology
- Clearance route
- De Novo
- Year authorized
- 2021
- Modality
- Digital pathology
- Role in workflow
- Concurrent read
Pathology should have been an obvious early target for medical AI and was not, for an unglamorous reason: the slides were not digital. Radiology has been digital since the 1990s. Most pathology labs still cut glass, and a model cannot analyze an image that does not exist. Whole slide scanning had to arrive first.
That dependency is why this list contains hundreds of radiology devices and, in pathology, essentially this one.
Where It Is Used
- Prostate biopsy screening support
- Second-read quality assurance
- Prioritizing slides within a case
Limitations Worth Knowing
The device is an adjunct for a single tissue type and cancer, requires a validated whole slide imaging pipeline as a prerequisite, and inherits every scanning artifact that pipeline produces. The pathologist remains the diagnostician, and unmarked regions carry no negative assurance.
Regulatory status, indications, and labeling change over time. Confirm current status on the FDA's AI/ML-Enabled Medical Devices list and in the manufacturer's current instructions for use before relying on anything stated here.