MedCity News September 23, 2021
Paige received clearance from the Food and Drug Administration for a clinical decision support tool to flag potential prostate cancer cases for pathologists to review.
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.
It’s intended to help pathologists with large workloads and make it easier to identify potential areas of concern.
“There’s a lot of tissue. It can take a half hour or even an hour...
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