The FDA approval was based on a study where 6 pathologists examined 527 digitally scanned prostate biopsy slides. Of them, 171 were cancerous, and 356 were benign. The pathologist made two assessments, one with and one without the program's help.on individual slide images by 7.3% on average compared to unassisted reads. There was no impact on the reading of benign slides.
The FDA said that the risk for false negatives and false positives with the program is lessened because it is used along with a doctor and by the pathologists' consideration of patient history, laboratory studies, and other clinical information. “Pathologists examine biopsies of tissue suspected for diseases, such as prostate cancer, every day,” Tim Stenzel, MD, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA, said in a statement. “The authorization of this AI-based software can help increase the number of identified prostate biopsy samples with cancerous tissue, which can ultimately save lives.”
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