Memorial Sloan Kettering spinout gets first FDA clearance for AI to detect prostate cancer

The Food and Drug Administration cleared the first AI tool intended to flag potentially cancerous lesions from prostate tissue slides.

The software, developed by Memorial Sloan Kettering spinout Paige, analyzes digital slide images and matches patterns in the tissue to a cancer database. It was cleared through the FDA’s de novo pathway, creating a predicate for similar devices in the future.