The U.S. Food and Drug Administration authorized marketing of a software developed by Paige.AI, a provider of AI-based digital diagnostics, which could help pathologists to identify prostate cancer.
The software, called Paige Prostate, is the first and only artificial intelligence or AI-based pathology product to receive FDA approval for in vitro diagnostic or IVD use in detecting cancer in prostate biopsies.
The software can identify an area of interest on the prostate biopsy image with the highest likelihood of harboring cancer. It can be reviewed further by the pathologist if the area of concern has not been identified on initial review.
The authorization of the AI-based software is expected to help increase the number of identified prostate biopsy samples with cancerous tissue, which can ultimately save lives.
The FDA noted that Paige Prostate is compatible for use with slide images that have been digitized using a scanner. The digitized slide image can then be visualized using a slide image viewer.
Prostate cancer, which starts in the prostate, is the most common cancer among men in the United States, aside from non-melanoma skin cancer, according to the Centers for Disease Control and Prevention.
The regulator’s decision is based on the review of data from a clinical study where 16 pathologists examined 527 slide images of prostate biopsies that were digitized using a scanner. For each slide image, each pathologist completed two assessments, one without Paige Prostate’s assistance and one with Paige Prostate’s assistance. The study found that Paige Prostate improved detection of cancer on individual slide images by 7.3% on average.
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