FDA clears first AI software application for prostate disease


Designed to complement the pathologist’s review of scanned prostate biopsy images, Paige Prostate identifies areas of interest on images that contain the highest likelihood of cancer. Pathologists can then further examine the AI ​​results if they had not identified these areas of concern during their initial assessment, according to the FDA.

This ability can help pathologists make a diagnosis that informs appropriate treatment, according to Dr. Tim Stenzel, PhD, of the FDA Center for Devices and Radiological Health.

“Authorization of this AI-based software may help increase the number of prostate biopsy samples identified with cancerous tissue, which may ultimately save lives,” Stenzel said in an FDA statement. .

The FDA review included the evaluation of data from a clinical study involving 16 pathologists and 527 slide images of prostate biopsies scanned using a scanner. All pathologists evaluated each slide twice, first without Paige Prostate, then with the help of the software. The study concluded that Paige Prostate resulted in a 7.3% increase in cancer detection compared to reads by an unassisted pathologist for whole slide images. The software had no effect on the interpretations of the benign images, the FDA said.

The FDA cleared Paige Prostate for sale after a review as part of its de novo pre-market pathway for new types of devices deemed to be low to moderate risk. In addition, the FDA also established new controls – including labeling and performance testing requirements – for this new regulatory classification. Subsequent devices of the same type and intended use will now be able to go through the FDA 510 (k) pre-market process.

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