www.fdanews.com/articles/211696-fda-clears-bot-images-ai-software-for-prostate-cancer-screening
FDA Clears Bot Image’s AI Software for Prostate Cancer Screening
April 3, 2023
The FDA has granted clearance to Bot Image’s ProstatID AI software for analysis of non-contrast “short form” magnetic resonance imaging (MRI) scans to screen for prostate cancer.
The AI software eliminates the use of MRI contrast dye that uses gadolinium, a known toxic metal, that can potentially build up in the brain and kidneys with possible side effects.
Eliminating the contrast dye from prostate cancer MRIs enables more frequent, low-cost scans for active surveillance, the company said.
Clinical studies showed that the ProstatID algorithm has an accuracy of 93.6 percent for detection of prostate cancer.
Related Topics