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FDA Authorizes AI Software Designed to Help Spot Prostate Cancer

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The Paige Prostate software is designed to identify areas in pathology images that may indicate prostate cancer.

The U.S. Food and Drug Administration said Paige Prostate is the first artificial intelligence-based software program it has authorized that is designed to identify areas of interest in prostate biopsy.

Credit: Paige AI Inc.

The U.S. Food and Drug Administration (FDA) last week authorized the use of the first artificial intelligence (AI) tool designed to help diagnose prostate cancer.

Startup Paige.AI's Paige Prostate software analyzes and compares digital scans of prostate biopsy slides to datasets of cell and tissue patterns previously identified as tumor indicators.

The FDA said the tool is the first authorized AI-based software algorithm programmed to identify areas of interest in prostate biopsy.

Paige submitted a clinical trial to the FDA, showing Paige Prostate helped pathologists identify cancer signs 96.8% of the time, compared to 89.5% for manual image viewing.

Said Paige's Leo Grady, "Paige Prostate will actually improve the accuracy and the quality of the diagnosis, providing better care to these patients."

From The Wall Street Journal
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